Bone VCAR (BVCAR)

System, X-ray, Tomography, Computed

GE Medical Systems SCS

The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Bone Vcar (bvcar).

Pre-market Notification Details

Device IDK183204
510k NumberK183204
Device Name:Bone VCAR (BVCAR)
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
ContactElizabeth Matthew
CorrespondentElizabeth Matthew
GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-04-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.