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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K232361
Device Name Promaxo MRI System II
Applicant
Promaxo, Inc.
70 Washington St., Suite 407
Oakland,  CA  94607
Applicant Contact Veronica Sanz
Correspondent
Promaxo, Inc.
70 Washington St., Suite 407
Oakland,  CA  94607
Correspondent Contact Veronica Sanz
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received08/07/2023
Decision Date 09/05/2023
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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