Data / Medical devices / Switzerland / Medimaps Group SA
Medimaps Group SA: FDA-registered device maker in Plan-les-Ouates Geneve, Switzerland, 2 510(k) clearances
Medimaps Group SA is registered with the FDA (registration 3010208539) in Plan-les-Ouates Geneve, Switzerland. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated January 17, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010208539
- Address
- 36A Chemin Du Champ des Filles, Plan-les-Ouates Geneve, Switzerland, CH-1228
- Owner or operator
- Medimaps SA (10042744)
- Roles
- Manufacturer
- First device listed
- May 10, 2022
- Registered through
- 2026
- Brand names listed
- TBS iNsight, TBS iNsight (V4)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2025 | K243218 | TBS iNsight (V4) | KGI | Substantially Equivalent | Medimaps Group SA | accessdata.fda.gov |
| April 29, 2016 | K152299 | TBS iNsight | KGI | Substantially Equivalent | Medimaps Group SA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2025 | 96233 | Class II | Ongoing | 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 iNsight is a class II Me | Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. | accessdata.fda.gov |
| October 3, 2016 | 75510 | Class II | Terminated | 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. | The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been computed from a spine scan where some vertebrae were excluded. | accessdata.fda.gov |
Compare with other makers
Updated February 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.