K233342 is an FDA 510(k) clearance for the CINA-ASPECTS. This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code POK).
Submitted by Avicenna.Ai (La Ciotat, FR). The FDA issued a Cleared decision on March 15, 2024, 168 days after receiving the submission on September 29, 2023.
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 | K233342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | March 15, 2024 |
| Days to Decision | 168 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 |