Embedded integration
C++ configuration for third-party ultrasound systems, with OEM responsibility for UI integration and final validation.
exact submission · checked 2026-09-05FDA-cleared profile
Sonio Suspect
Sonio
Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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.
- Intended users
- Interpreting physicians, including maternal-fetal medicine specialists, OB/GYNs and radiologists.
- Care setting and population
- Adult
Baseline ACR patient-population label retained; the imaging target is fetal anatomy, not adult organs.
- Workflow role
- Concurrent detection and characterization aid
- Required input
- Fetal ultrasound images acquired at gestational age 11-41 weeks, with finding-specific trimester and view restrictions.
- 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.
- 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.
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.
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.
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.
- Security and privacy
- Vendor documentation pending
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
OEM-specific operator training, escalation and competency materials were not established.
- Monitoring and change control
- Vendor documentation pending
Completed real-world integration testing and ongoing clinical monitoring commitments were not verified.
Integration rollout context
The dated vendor announcement describes real-world integration testing as the next phase after clearance.
exact submission · checked 2026-09-05Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- 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.
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%)
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%)
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
Bench comparison using predicate protocol and dataset criteria after conversion to embedded C++ · Fetal ultrasound views for the specified abnormal findings within labeled gestational-age restrictions
exact submission · Tested version: Sonio Suspect K261519 integration configuration compared with cloud configuration · Sponsor or vendor studyK261519
Algorithms, weights and thresholds were unchanged. Public summary provides average sensitivity/specificity and confidence intervals, but not a sample total or prospective clinical outcomes.
Economics and lifecycle
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
No OEM integration license or site price is established by the reviewed announcement or summary.
- Reimbursement and coding
- Research pending
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
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
- Verify security and privacy controls: Exact OEM integration security, update responsibility and scoped dated certification evidence remain unverified; cloud-platform claims do not automatically apply to an embedded configuration.
- Verify training: OEM-specific operator training, escalation and competency materials were not established.
- Verify pricing and total cost: No OEM integration license or site price is established by the reviewed announcement or summary.
- Verify reimbursement and coding relevance: No applicable payer coverage/payment policy was reviewed.
- Verify local validation and lifecycle monitoring: Completed real-world integration testing and ongoing clinical monitoring commitments were not verified.
- Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
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
0Reviewed PubMed leads
0Reviewed 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
Source ledger
Sources accessed through 2026-09-05.
- Sonio Suspect: K261519 Special 510(k) summary U.S. Food and Drug Administration · 2026-09-05
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Sonio Suspect model card (K261519) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- Sonio receives FDA clearance for Sonio Suspect Integration Configuration Sonio · 2026-09-05
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