K221564 is an FDA 510(k) clearance for the Brainomix 360 e-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 Brainomix Limited (Oxford, GB). The FDA issued a Cleared decision on February 23, 2023, 268 days after receiving the submission on May 31, 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 | K221564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | February 23, 2023 |
| Days to Decision | 268 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 |