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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 K133848
Device Name RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
Applicant
Heartvista, Inc.
998 Hamilton Ave.
Menlo Park,  CA  94025
Applicant Contact JAMES J ROGERS
Correspondent
Heartvista, Inc.
998 Hamilton Ave.
Menlo Park,  CA  94025
Correspondent Contact JAMES J ROGERS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/18/2013
Decision Date 06/25/2014
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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