Company ยท CH
Medimaps Group SA
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KGI | Densitometer, Bone | 5 |
Latest 510(k) clearances
Latest recalls
| 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 | K152299 |
| 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 | K152299 |