K221624 is an FDA 510(k) clearance for the Avenda Health AI Prostate Cancer Planning Software. This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code POK).
Submitted by Avenda Health, Inc. (Culver City, US). The FDA issued a Cleared decision on November 22, 2022, 169 days after receiving the submission on June 6, 2022.
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 | K221624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2022 |
| Decision Date | November 22, 2022 |
| Days to Decision | 169 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 |