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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 K260092
Device Name Vista AI Scan
Applicant
Vista AI, Inc.
431 Florence St.
Suite 100
Palo Alto,  CA  94301
Applicant Contact James Rogers
Correspondent
Vista AI, Inc.
702 Marshall Street
Suite 280
Redwood City,  CA  94063
Correspondent Contact James Rogers
Regulation Number892.1000
Classification Product Code
LNH  
Date Received01/12/2026
Decision Date 10/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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