Radiology AI Directory

FDA-cleared profile

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

The Samsung V-family diagnostic ultrasound systems support fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, thoracic, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, intraoperative, and dermatologic applications where labeled.

Cardiac imagingUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
The Samsung V-family diagnostic ultrasound systems support fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, thoracic, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, intraoperative, and dermatologic applications where labeled.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.

Intended users
Qualified physicians, sonographers, and other trained ultrasound professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Hospitals, clinics, offices, operating rooms, and point-of-care environments within the cleared applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Ultrasound acquisition, measurement, analysis, reporting, and release-specific AI assistance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Live or imported ultrasound data from supported probes, systems, host devices, and applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Ultrasound images, measurements, calculations, overlays, and reports for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K250999
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-07-18
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K250999; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Ultrasound hardware or software with supported probes, host devices, licensed options, and network configuration.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K250999; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified physicians, sonographers, and other trained ultrasound professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K250999; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K250999 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K250999 reports AI fetal-biometry testing on 320 images from 52 patients in two countries, with Dice 0.869 and distance or circumference errors within the stated limits. ViewAssist testing included 680 images from 102 patients; fetal HeartAssist testing included 280 images from 70 patients. The reported performance is function-specific and does not characterize every V-family workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
0.9397 ViewAssist fetal-biometry sensitivity and 0.9429 fetal HeartAssist sensitivity; endpoint-specific
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Endpoint-specific value reported in the exact FDA performance package; compare only with matching endpoint, threshold, population, and version.

Reported specificity
0.9962 for the reported ViewAssist and fetal HeartAssist evaluations; endpoint-specific
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Endpoint-specific value reported in the exact FDA performance package; compare only with matching endpoint, threshold, population, and version.

Fetal-biometry Dice

0.869 coefficient

  • EndpointSegmentation overlap
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

Fetal-biometry image set

320 images

  • EndpointAI fetal-biometry evaluation
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

ViewAssist sensitivity

0.9397 proportion

  • EndpointFetal-biometry view assistance
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

ViewAssist specificity

0.9962 proportion

  • EndpointFetal-biometry view assistance
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

ViewAssist Dice

0.863 coefficient

  • EndpointFetal-biometry segmentation overlap
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

Fetal HeartAssist sensitivity

0.9429 proportion

  • EndpointFetal cardiac measurement assistance
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

Fetal HeartAssist specificity

0.9962 proportion

  • EndpointFetal cardiac measurement assistance
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

Fetal HeartAssist Dice

0.865 coefficient

  • EndpointFetal cardiac segmentation overlap
  • PopulationV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
Source

K250999 FDA performance package for V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

  • DesignManufacturer AI fetal-biometry, view-assistance, and cardiac-measurement validation
  • PopulationFetal biometry: 320 images and 52 patients; ViewAssist: 680 images and 102 patients; fetal HeartAssist: 280 images and 70 patients
  • Scopeexact submission
  • Tested versionV8/cV8/V7/cV7/V6/cV6/V5/cV5/V4/cV4 Diagnostic Ultrasound Systems
  • IndependenceSponsor or vendor study

K250999

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

5 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K250999 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
13Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

Twenty PubMed records and ten trial records were screened. They address diagnostic ultrasound generally or unrelated interventions and do not identify the exact Samsung V-family release cleared in K250999. No evidence was promoted, and all 30 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K250999: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System

    U.S. Food and Drug Administration - Published 2025-07-18 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Samsung V8 diagnostic ultrasound system overview

    Samsung Healthcare - Accessed 2026-09-03

    Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext

  8. Diagnostic ultrasound widespread.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. Diagnostic ultrasound imaging.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  14. Penile Evaluation: An Illustrated Review.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  15. Sonographic Diagnosis of Carpal Tunnel Syndrome.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  16. Safety Considerations for Diagnostic Ultrasound in the Eye.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  17. Diagnostic ultrasound performed by a physician as a dialog.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  18. Diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  19. Diagnostic Ultrasound of the Soleal Sling.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  20. Nonlinear acoustics in diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  21. Hazards, risks and safety of diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  22. [Ultrasound screening and diagnostic ultrasound: should we revise the classification of examinations?].

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  23. Acoustic cavitation and the safety of diagnostic ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  24. The cost of waiting: diagnostic ultrasound delays in ectopic pregnancy.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  25. Assessment of Repaired Diagnostic Ultrasound Probes.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  26. Hepatocyte Injury Induced by Contrast-Enhanced Diagnostic Ultrasound.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  27. Diseases of the thorax.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  28. Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  29. Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary Incontinence

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  30. Androgen Responses to hCG and Ovarian Morphology in PCOS

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  31. Effects of Physical Exercise in Type 2 Diabetics

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  32. Cardiovascular Risk and Functional Responses From Dancing at Home in the Elderly With and Without Type 2 Diabetes

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  33. Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  34. Gynacological Imaging Reporting and Data System in Ovarian Masses by Ultrasonography

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  35. External Phase MRI in Diagnosis of OASI

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  36. Fecal Incontinence Subtypes in Women With Pelvic Floor Disorders

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  37. Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K250999 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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