The following data is part of a premarket notification filed by Medimaps Group Sa with the FDA for Tbs Insight.
| Device ID | K152299 |
| 510k Number | K152299 |
| Device Name: | TBS INsight |
| Classification | Densitometer, Bone |
| Applicant | MEDIMAPS GROUP SA 18, CHEMIN DES AULX Plan Les Ouates, CH 1228 |
| Contact | Christophe Lelong |
| Correspondent | Christophe Lelong MEDIMAPS GROUP SA 18, CHEMIN DES AULX Plan Les Ouates, CH 1228 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-13 |
| Decision Date | 2016-04-29 |
| Summary: | summary |