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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K233582
Device Name Rapid
Applicant
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Applicant Contact Dr. Subok Park
Correspondent
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received11/02/2023
Decision Date 04/22/2024
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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