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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 K212233
Device Name RTHawk, HeartVista Cardiac Package
Applicant
Heartvista, Inc.
2625 Middlefield Rd., #710
Palo Alto,  CA  94306
Applicant Contact James J Rogers
Correspondent
Heartvista, Inc.
2625 Middlefield Rd., #710
Palo Alto,  CA  94306
Correspondent Contact James J Rogers
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/16/2021
Decision Date 10/05/2021
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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