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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 K183274
Device Name RTHawk, HeartVista Cardiac Package
Applicant
Heartvista, Inc.
4984 El Camino Real, Suite 102
Los Altos,  CA  94022
Applicant Contact James J. Rogers
Correspondent
Heartvista, Inc.
4984 El Camino Real, Suite 102
Los Altos,  CA  94022
Correspondent Contact James J. Rogers
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/23/2018
Decision Date 10/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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