K253884
- 510(k) number
- K253884
- Device name
- Koios DS (3.8)
- Applicant
- Koios Medical, Inc. NY · US
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2026-07-02
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K253884.pdf
Official FDA record: K253884
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.