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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 K233030
Device Name BoneMRI
Applicant
Mriguidance B.V.
Maliesingel 23
Utrecht,  NL 3581 BG
Applicant Contact David Sparks
Correspondent
Maxis Medical
3031 Tisch Way
Suite 1010
San Jose,  CA  95128
Correspondent Contact Sujith Shetty
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/25/2023
Decision Date 03/01/2024
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		 Yes
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