K242130
- 510(k) number
- K242130
- Device name
- Koios DS
- Applicant
- Koios Medical, Inc. NY · US
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-11-15
- Date received
- 2024-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242130.pdf
Official FDA record: K242130
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.