Radiology AI Directory

FDA-cleared profile

Sonio Detect

Sonio

Concurrent aid during acquisition and interpretation of fetal ultrasound examinations across gestational ages 11-37 weeks to detect supported views and structures and verify view quality criteria and characteristics.

Cardiac imagingDetection and CADeUltrasound 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
Concurrent aid during acquisition and interpretation of fetal ultrasound examinations across gestational ages 11-37 weeks to detect supported views and structures and verify view quality criteria and characteristics.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Sonographers, OB/GYN maternal-fetal medicine specialists, and fetal surgeons as healthcare professionals
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Clinical fetal ultrasound acquisition and interpretation workflow
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Real-time concurrent acquisition and interpretation aid for exam completeness and protocol checking; the healthcare professional can reassign or unassign views and override quality or characteristic outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Fetal ultrasound images and clips from GE Medical, Samsung, Canon, or Philips ultrasound machines, covering trimester 1, 2, or 3 and gestational age 11-37 weeks; DICOM instances are received by edge software on a server connected to the ultrasound-machine network.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic detection of 7 first-trimester or 18 second/third-trimester views, supported fetal anatomical structures, presence or absence quality criteria, placenta location (anterior/posterior), and fetal sex (male/female), with yellow highlighting for unverified items and user-editable assignments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The packet states that Sonio Detect was validated only with GE, Canon, Philips, and Samsung ultrasound devices and is intended only for those vendors. Outputs are concurrent reading aids that can be overridden by the user; the packet does not establish a diagnostic conclusion or a clinical-outcome claim. No clinical study was required for substantial equivalence.
  • 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
K240406
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Fetus/obstetric anatomy, including fetal brain, heart/thorax, abdomen, placenta, and genitalia
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-04-26
  • 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
The packet describes edge software on a local server receiving DICOM instances from the ultrasound machine, uploading them to Sonio Cloud, and SaaS access through an internet browser, with Chrome recommended. It does not establish a specific PACS, RIS, EHR, interface version, or pure cloud-only deployment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • 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.

ACR exact-submission catalog context

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

exact submission ยท 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 K240406 reports standalone performance testing on 36,769 fetal ultrasound images using a global validation dataset independent of development and operating-point data. The table reports endpoint-specific sensitivity and specificity: view sensitivity was 0.914 for 7 first-trimester views and 0.937 for 18 second/third-trimester views; paired structure or characteristic results included brain 0.934/0.949, thorax and heart 0.861/0.938 for trimester 1 and 0.919/0.976 for trimesters 2/3, placenta structures 0.967/0.856, CRL/NT/profile 0.898/0.862 for trimester 1 and 0.893/0.956 for trimesters 2/3, anterior placenta location 0.959/0.966, posterior location 0.966/0.959, female sex 0.977/0.987, and male sex 0.987/0.977. The table also reports sensitivity-only values of 0.892 for 3D-image detection, 0.973 for Doppler-image detection, and 0.913 for view detection from image annotations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Endpoint-specific, not device-level: fetal brain 93.4%; fetal thorax/heart 86.1% at T1 and 91.9% at T2/T3; additional view and characteristic rows are reported in the FDA table.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K240406 reports separate trimester-, view-, structure-, and characteristic-specific endpoints; the prior 95%/95% pair was not an observed overall result.

Reported specificity
Endpoint-specific, not device-level: fetal brain 94.9%; fetal thorax/heart 93.8% at T1 and 97.6% at T2/T3; specificity is not reported for some image-type endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K240406 reports separate trimester-, view-, structure-, and characteristic-specific endpoints; the prior 95%/95% pair was not an observed overall result.

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

Sonio Detect regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K240406
  • Samplen=36769
  • IndependenceIndependence not established

K240406

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 K240406 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 K240406. 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
23Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting 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 0 PubMed and 0 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 K240406: Sonio Detect

    U.S. Food and Drug Administration - Published 2024-04-26 - 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. Sonio Detect model card (K240406)

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

    Scope: intendedUsers, output, evidenceSummary, anatomy, evidenceStudies

  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 K240406

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

    Scope: postmarketSafety

Research history

  1. K240406 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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