K220822 is an FDA 510(k) clearance for the 3D-SHAPER. This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by 3D-Shaper Medical S.L (Barcelona, ES). The FDA issued a Cleared decision on December 9, 2022, 263 days after receiving the submission on March 21, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K220822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2022 |
| Decision Date | December 09, 2022 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KGI - Densitometer, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1170 |