Radiology AI Directory

FDA-cleared profile

Sonio Detect

Sonio

Authorized purpose: Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid during acquisition and interpretation.

Detection 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.

Product overview

Start with the essentials

Authorized purpose: Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid during acquisition and interpretation.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid during acquisition and interpretation.

Evidence takeaway

Evidence from the reviewed source record: Standalone bench testing used 17,885 fetal-ultrasound images from seven clinical sites in the United States, France, and Germany, independent of model-development data. Reported endpoints included 3D-image detection sensitivity 0.980 (95% Wilson CI 0.930-0.994), Doppler-image sensitivity 0.963 (0.908-0.985), annotation-reading proportion correct 0.923 (0.905-0.938), some T1-view sensitivity 0.942, some T2/T3-view sensitivity 0.919, fetal-brain structure sensitivity/specificity 0.857/0.963, fetal-heart structure sensitivity/specificity 0.900/0.982, and brain-view zoom sensitivity/specificity 0.952/0.906 (95% Wilson CIs 0.909-0.976 and 0.758-0.968). Clinical studies were stated to be not applicable for substantial equivalence.

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
Analyze fetal ultrasound images and clips to automatically detect views, detect anatomical structures within views, and verify view-quality criteria as a concurrent reading aid during acquisition and interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Qualified and trained healthcare professionals in prenatal ultrasound, including sonographers, maternal-fetal-medicine specialists, OB/GYNs, and fetal surgeons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Professional prenatal ultrasound imaging environment across first, second, and third trimesters; the FDA device description states a gestational-age range of 11-37 weeks and does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Concurrent acquisition and interpretation support that labels views, detects structures, verifies quality criteria, and lets the healthcare professional review or override assignments and verification status.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Fetal ultrasound images and clips received from an ultrasound machine through the Edge Software; the FDA description covers first-, second-, and third-trimester examinations and real-time processing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Automatically detected views, anatomical structures within supported views, and verified or not-verified standardized quality criteria, including structure presence/absence and zoom level; users can reassign or edit the results.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The FDA packet states that Sonio Detect was validated and is intended only for GE, Canon, and Samsung ultrasound devices. Performance statements apply to the tested view, structure, annotation, and quality-criterion endpoints, including only some views and structures, not to an unrestricted fetal-ultrasound claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K230365
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Fetus and fetal anatomy
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-07-25
  • 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 FDA description states that Edge Software runs on a server on the same network as the ultrasound machine, receives DICOM instances, uploads them to Sonio Cloud, and provides SaaS access through an internet browser; exact current interfaces and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

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 · checked 2026-09-09
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
Standalone bench testing used 17,885 fetal-ultrasound images from seven clinical sites in the United States, France, and Germany, independent of model-development data. Reported endpoints included 3D-image detection sensitivity 0.980 (95% Wilson CI 0.930-0.994), Doppler-image sensitivity 0.963 (0.908-0.985), annotation-reading proportion correct 0.923 (0.905-0.938), some T1-view sensitivity 0.942, some T2/T3-view sensitivity 0.919, fetal-brain structure sensitivity/specificity 0.857/0.963, fetal-heart structure sensitivity/specificity 0.900/0.982, and brain-view zoom sensitivity/specificity 0.952/0.906 (95% Wilson CIs 0.909-0.976 and 0.758-0.968). Clinical studies were stated to be not applicable for substantial equivalence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
FDA endpoint-specific sensitivity: 3D fetal-ultrasound image detection 0.980 (95% Wilson CI 0.930-0.994); Doppler image detection 0.963 (0.908-0.985); some T1 views 0.942 point estimate; some T2/T3 views 0.919 point estimate; some fetal-brain structures 0.857 point estimate; some fetal-heart structures 0.900 point estimate; brain-view zoom verification 0.952 (95% Wilson CI 0.909-0.976).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA reports multiple view-, image-type-, structure-, and quality-criterion sensitivities; the baseline's isolated 0.980 value is not a device-wide endpoint.

Reported specificity
FDA endpoint-specific specificity: some fetal-brain structures 0.963 point estimate; some fetal-heart structures 0.982 point estimate; brain-view zoom verification 0.906 (95% Wilson CI 0.758-0.968).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

Specificity is reported only for bounded structure and zoom-quality endpoints; annotation-reading proportion correct and view-detection sensitivities are separate measures.

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 K230365
  • Samplen=17885
  • Sites7
  • IndependenceIndependence not established

K230365

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 2026-09-09

No public price or quote for the exact K230365 configuration was established in this review.

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

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 K230365. 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 2026-09-09

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
2026-09-20Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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, 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 K230365: Sonio Detect

    U.S. Food and Drug Administration - Published 2023-07-25 - Accessed 2026-09-09

    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 (K230365)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, reportedSensitivity, evidenceSummary, 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 K230365

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

    Scope: postmarketSafety

Research history

  1. K230365 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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