K221949 is an FDA 510(k) clearance for the Ortho Device, ADAPTIX 3D Orthopedic Imaging System. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Pausch Medical GmbH (Erlangen, DE). The FDA issued a Cleared decision on January 26, 2023, 205 days after receiving the submission on July 5, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K221949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | January 26, 2023 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZF - System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |