K243077 is an FDA 510(k) clearance for the Affirm 800. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) (Goleta, US). The FDA issued a Cleared decision on June 27, 2025, 270 days after receiving the submission on September 30, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K243077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 27, 2025 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |