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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K202404
Device Name BoneMRI
MRIguidance B.V
Gildstraat 91a
Utrecht,  NL 3572 EL
Applicant Contact Roel Raatgever
Maxis Medical
7052 Hollow Lake Way
San Jose,  CA  95120
Correspondent Contact Suji Shetty
Regulation Number892.2050
Classification Product Code
Date Received08/21/2020
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No