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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K251987
Device Name Rapid Aortic Measurements
Applicant
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Applicant Contact Jim Rosa
Correspondent
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/27/2025
Decision Date 09/23/2025
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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