Radiology AI Directory

FDA-cleared profile

Sonio Suspect

Sonio

Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.

Ultrasound 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 physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Interpreting physicians, including maternal-fetal medicine specialists, OB/GYNs and radiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Baseline ACR patient-population label retained; the imaging target is fetal anatomy, not adult organs.

Workflow role
Concurrent detection and characterization aid
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
Fetal ultrasound images acquired at gestational age 11-41 weeks, with finding-specific trimester and view restrictions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Flags for great-vessel malposition; absent or unusually sized vessel in the three-vessel view; ventricular disequilibrium or absence; thoracic or abdominal situs inversus; absent single stomach bubble or abnormally large stomach; absent cavum septum pellucidum; and absent corpus callosum.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Only the specified findings and supported views/gestational ranges are covered. This is a concurrent aid, not a comprehensive exclusion of fetal abnormality or a standalone management decision.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K261519
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Obstetric/Fetal
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-06-04
  • 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 third-party manufacturer is responsible for user-interface integration and final system validation; the integrated configuration must meet minimum hardware requirements.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

The summary does not provide a procurement-ready list of compatible machine models or complete hardware specifications.

Deployment and data flow
K261519 adds a C++ integration configuration for third-party ultrasound systems to the existing Python web-based/cloud configuration, with the algorithm logic, weights and thresholds unchanged.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Exact OEM integration security, update responsibility and scoped dated certification evidence remain unverified; cloud-platform claims do not automatically apply to an embedded configuration.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

OEM-specific operator training, escalation and competency materials were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Completed real-world integration testing and ongoing clinical monitoring commitments were not verified.

Embedded integration

C++ configuration for third-party ultrasound systems, with OEM responsibility for UI integration and final validation.

exact submission · checked 2026-09-05
Source

Integration rollout context

The dated vendor announcement describes real-world integration testing as the next phase after clearance.

exact submission · checked 2026-09-05
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
Bench comparison of integration and cloud configurations used the predicate protocol/dataset criteria. Integration average sensitivity was 92.5% and specificity 90.4%; this was not a new prospective clinical-outcome study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Public summary does not report a single test sample total. The averages should not be interpreted as per-abnormality performance.

Reported sensitivity
92.5% (95% CI 90.9%-93.9%)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Average for the K261519 integration configuration in standalone bench testing of the specified fetal findings under predicate protocol/dataset criteria. Sample total is not stated in the summary; no prospective screening-population sensitivity is inferred.

Reported specificity
90.4% (95% CI 89.1%-91.7%)
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Average for the K261519 integration configuration in standalone bench testing of the specified fetal findings under predicate protocol/dataset criteria. Sample total is not stated in the summary; not a per-finding or real-world prevalence-adjusted estimate.

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

K261519 cloud-to-integration standalone performance comparison

  • DesignBench comparison using predicate protocol and dataset criteria after conversion to embedded C++
  • PopulationFetal ultrasound views for the specified abnormal findings within labeled gestational-age restrictions
  • Scopeexact submission
  • Tested versionSonio Suspect K261519 integration configuration compared with cloud configuration
  • IndependenceSponsor or vendor study

K261519

Algorithms, weights and thresholds were unchanged. Public summary provides average sensitivity/specificity and confidence intervals, but not a sample total or prospective clinical outcomes.

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 2026-09-05

No OEM integration license or site price is established by the reviewed announcement or summary.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer coverage/payment policy was reviewed.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-06

Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-05Last searched
20Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata contained no PubMed or trial records for this ID; this is not a claim that no literature exists. 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, acr ai central product, fda decision summary, vendor announcement, stored candidate metadata, 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. Sonio Suspect: K261519 Special 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, deployment, integration, reportedSensitivity, reportedSpecificity, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Sonio Suspect model card (K261519)

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

    Scope: purpose, modality, intendedUsers, careSetting, output, reportedSensitivity, reportedSpecificity, 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. Sonio receives FDA clearance for Sonio Suspect Integration Configuration

    Sonio - Published 2026-06-24 - Accessed 2026-09-05

    Scope: deployment, implementationCapabilities, commercialAvailability

Research history

  1. K261519 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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Sonio Suspect

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Concurrent or post-exam fetal ultrasound aid that identifies and characterizes eight abnormal findings for interpreting-physician review; not the sole basis for management.

Modality
Ultrasound
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