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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 K251029
Device Name Vista OS, Vista AI Scan, RTHawk
Applicant
Vista Ai, Inc.
431 Florence St.
Suite 100
Palo Alto,  CA  94301
Applicant Contact James Rogers
Correspondent
Heartvista, Inc. Dba Vista.Ai
431 Florence St.
Suite 100
Palo Alto,  CA  94301
Correspondent Contact James Rogers
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/02/2025
Decision Date 08/21/2025
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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