K243218 is an FDA 510(k) clearance for the TBS iNsight (V4). This device is classified as a Densitometer, Bone (Class II - Special Controls, product code KGI).
Submitted by Medimaps Group SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on January 17, 2025, 105 days after receiving the submission on October 4, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1170.
| 510(k) Number | K243218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 105 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 |