Radiology AI Directory

FDA-cleared profile

DEEPECHO

DeepEcho

Detect standard fetal biometry views and assist fetal biometry measurements during prenatal ultrasound acquisition and interpretation.

Detection and CADeQuantification and segmentationUltrasound 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
Detect standard fetal biometry views and assist fetal biometry measurements during prenatal ultrasound acquisition and interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified and appropriately trained healthcare professionals, including radiologists, obstetricians, sonographers, maternal-fetal medicine specialists, OB/GYNs, and fetal surgeons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Prenatal/obstetric ultrasound clinical care; the FDA validation dataset included tertiary maternal-fetal medicine and community-based health settings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Concurrent view-identification and measurement aid during ultrasound acquisition and interpretation; not a stand-alone diagnostic decision maker.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM fetal ultrasound images or clips, or live fetal ultrasound video streamed from a scanner through local HDMI-to-USB capture. Live video supports view identification and caliper suggestions but cannot automatically compute measurements because it is not DICOM; DICOM is required for automated biometric computation. Labeled use is patients age 18 or older at 14 to 41 weeks; validation used 2D grayscale data and four listed ultrasound system families.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Identified and labeled cephalic, abdominal, and femoral views; suggested caliper placement; HC, BPD, FL, and AC measurements; and examination reports. The device description also describes GA and EFW computation after view detection and DICOM processing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The labeled use is not first trimester, Doppler, or 3D acquisition. The device was validated only on Butterfly iQ3, GE Voluson S8/S10/E6, Clarius HD3, and Philips IU22/HD7 systems in the packet's study. The IFU is for patients age 18 or older, while the validation demographics report maternal age 15-56; the evidence population is therefore not identical to the labeled population.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K242594
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Fetal biometry views and structures: cephalic/head, abdomen, and femur
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-05-23
  • 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
Cloud-based standalone SaMD accessible from laptops, tablets, or desktops without a local server; DICOM upload links or creates patient/exam records from metadata, while live scanner video uses HDMI-to-USB capture into the local device. The packet does not establish a specific PACS/RIS/EHR interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Hybrid
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for DEEPECHO; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

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
FDA packet: stand-alone assessment against annotations by three ARDMS-certified sonographers. 417 studies from 15 sites were collected; after exclusions, 397 subjects and 23,544 images remained. Endpoints covered four continuous measurement comparisons and view-identification sensitivity/specificity; no literature review was performed for this audit.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Abdominal View: 86.9% (95% CI: 83.8%, 89.7%) , Cephalic View: 98.2% (95% CI: 97.4%, 99%) , Femoral View: 91.8% (95% CI: 89%, 94.2%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
Abdominal View: 96.8% (95% CI: 96.4%, 97.2%) , Cephalic View: 94.8% (95% CI: 94.2%, 95.3%) , Femoral View: 97.4% (95% CI: 97%, 97.8%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

DEEPECHO regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K242594
  • Samplen=397
  • Sites15
  • IndependenceIndependence not established

K242594

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K242594 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K242594. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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.

Exact FDA record reviewedStatus
2026-09-08Last searched
25Fields reviewed
9Source classes checked
1Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 1 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, 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 K242594: DEEPECHO

    U.S. Food and Drug Administration - Published 2025-05-23 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. DEEPECHO model card (K242594)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K242594

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K242594 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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