Sonio Suspect

Evidence summary

FDA bench testing used 8,745 images from 1,115 examinations at 75 sites and reported sensitivity 93.2% and specificity 90.8%; a separate 13-reader MRMC study used 750 images from 287 examinations at 47 sites and reported AUC 0.689 unassisted versus 0.909 assisted.

FDA source Exact FDA submission Checked 2026-09-06

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify security and privacy controls: Current family security and compliance statements were not treated as an exact K243614 attestation.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: No numeric price was published in the reviewed sources.
• Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event 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, vendor product page, vendor terms, peer reviewed publication, clinical trial registry, recall database, pubmed, clinical trials, openfda device recall

• K243614 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Sonio Suspect model card (K243614) 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
• FDA 510(k) decision record and summary reviewed for Sonio Suspect, K243614 U.S. Food and Drug Administration · 2026-09-06
• Sonio clinical workflow and interoperability platform Sonio · 2026-09-07
• Sonio Terms of Use Sonio · 2026-09-07