K231995 is an FDA 510(k) clearance for the AcuityUDR. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Radmedix, LLC (Dayton, US). The FDA issued a Cleared decision on October 25, 2023, 112 days after receiving the submission on July 5, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K231995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2023 |
| Decision Date | October 25, 2023 |
| Days to Decision | 112 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |