K261519
- 510(k) number
- K261519
- Device name
- Sonio Suspect
- Applicant
- Sonio FR
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2026-06-04
- Date received
- 2026-05-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K261519.pdf
Official FDA record: K261519
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.