K251022 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 September 5, 2025, 156 days after receiving the submission on April 2, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K251022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2025 |
| Decision Date | September 05, 2025 |
| Days to Decision | 156 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 |