510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medimaps Group SA

Plan-les-Ouates Geneve, CH

Medimaps Group SA appears in FDA device records in Plan-les-Ouates Geneve, CH. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Medimaps Group SA between 2012 and 2025. The busiest year on record is 2012, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medimaps Group SA, by decision year
YearClearances
20121
20161
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243218TBS iNsight (V4)KGISubstantially Equivalent
K152299TBS iNsightKGISubstantially Equivalent
K121716TBS INSIGHTKGISubstantially Equivalent

Registered establishments

FDA registered establishments for Medimaps Group SA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30102085393010208539Medimaps Group SA36A Chemin Du Champ des Filles, Plan-les-Ouates Geneve CH-1228 CH2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1250-2025Brand 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: NoPotential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.Class IIOpen, Classified
Z-0369-2017TBS 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain