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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 K221762
Device Name BoneMRI v1.4
Applicant
Mrlguidance B.V.
Gildstraat 91a
Utrecht,  NL 3572
Applicant Contact Marijn van Stralen
Correspondent
Maxis Medical
3031 Tisch Way
Suite 1010
San Jose,  CA  95128
Correspondent Contact Sujith Shetty
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/17/2022
Decision Date 11/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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