K213975 is an FDA 510(k) clearance for the KEOPS Balance Analyzer 3D. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by S.M.A.I.O (Saint Priest, FR). The FDA issued a Cleared decision on May 6, 2022, 137 days after receiving the submission on December 20, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K213975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2021 |
| Decision Date | May 06, 2022 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |