2 results
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35ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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.
FDA Recall
Terminated
·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016
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 Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No
FDA Recall
Open, Classified
·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025