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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 K230197
Device Name BoneMRI v1.6
Applicant
MRIguidance B.V.
Maliesingel 23
Utrecht,  NL 3581 BG
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 Received01/25/2023
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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