K242130 is an FDA 510(k) clearance for the Koios DS. This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code POK).
Submitted by Koios Medical, Inc. (New York, US). The FDA issued a Cleared decision on November 15, 2024, 116 days after receiving the submission on July 22, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2060. Assist Users In Characterizing Lesions Identified On Acquired Medical Images.
| 510(k) Number | K242130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2024 |
| Decision Date | November 15, 2024 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | POK - Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2060 |
| Definition | Assist Users In Characterizing Lesions Identified On Acquired Medical Images |