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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K191278
Device Name RSI-MRI+
Applicant
MultiModal Imaging Services Corporation (dba HealthLytix)
4747 Executive Dr, Suite 820
San Diego,  CA  92121
Applicant Contact Stephen Kosnosky
Correspondent
MultiModal Imaging Services Corporation (dba HealthLytix)
4747 Executive Dr, Suite 820
San Diego,  CA  92121
Correspondent Contact Stephen Kosnosky
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/13/2019
Decision Date 11/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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