BoneMRI V1.4

Automated Radiological Image Processing Software

MRlguidance B.V.

The following data is part of a premarket notification filed by Mrlguidance B.v. with the FDA for Bonemri V1.4.

Pre-market Notification Details

Device IDK221762
510k NumberK221762
Device Name:BoneMRI V1.4
ClassificationAutomated Radiological Image Processing Software
Applicant MRlguidance B.V. Gildstraat 91a Utrecht,  NL 3572
ContactMarijn Van Stralen
CorrespondentSujith Shetty
MAXIS Medical 3031 Tisch Way Suite 1010 San Jose,  CA  95128
Product CodeQIH  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-17
Decision Date2022-11-16

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