510(k) Report

FDA applicant

Medimaps Group SA

Plan Les Ouates, CH3 decisions2012–20252 recalls

FDA records 3 decisions for Medimaps Group SA (Plan Les Ouates, CH) from 2012 to 2025: 3 510(k) clearances. All are in product code KGI (Densitometer, Bone). Its devices cite 4 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Medimaps Group SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2012: 12016: 12025: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2025

2016: 12025: 1
2012high 1 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Medimaps Group SA by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGIDensitometer, Bone3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152299TBS iNsightMedimaps Group SA · 20162cite it
  • K121716TBS InsightMedimaps Group SA · 20121cites it

What has FDA decided for it lately?

  • K243218TBS iNsight (V4)Medimaps Group SA · 2025
  • K152299TBS iNsightMedimaps Group SA · 20162 recalls
  • K121716TBS InsightMedimaps Group SA · 2012

All 3 as Medimaps Group SA →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K152299Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x /…Feb 3, 2025Class II
  • K152299TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that…Oct 3, 2016Class II