510(k) K152299 ยท KGI Densitometer, Bone
TBS iNsight
| Applicant | Medimaps Group SA, Plan Les Ouates, CH |
| Decision | Substantially Equivalent, Apr 29, 2016 |
| Received | Aug 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2025 | Medimaps Group Brand Name: TBS Osteo
Product Name: TBS iNsight
Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi
Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0
Product Description: TBS iNsi Open, Classified |
KGI | None listed |
| Nov 5, 2016 | Medimaps Group TBS iNsight Version v.3.0.1
Product Usage:
TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management. Terminated |
KGI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.