K230095 is an FDA 510(k) clearance for the ScanX Swift 2.0, ScanX Swift View 2.0. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Durr Dental SE (Bietigheim-Bissingen, DE). The FDA issued a Cleared decision on February 6, 2023, 25 days after receiving the submission on January 12, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K230095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2023 |
| Decision Date | February 06, 2023 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |