Automated Radiological Image Processing Software

MRIguidance B.V

The following data is part of a premarket notification filed by Mriguidance B.v with the FDA for Bonemri.

Pre-market Notification Details

Device IDK202404
510k NumberK202404
Device Name:BoneMRI
ClassificationAutomated Radiological Image Processing Software
Applicant MRIguidance B.V Gildstraat 91a Utrecht,  NL 3572 El
ContactRoel Raatgever
CorrespondentSuji Shetty
Maxis Medical 7052 Hollow Lake Way San Jose,  CA  95120
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-21
Decision Date2021-12-22

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