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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 K243378
Device Name Rapid MLS
Applicant
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Applicant Contact James Rosa
Correspondent
Ischemaview, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Correspondent Contact James Rosa
Regulation Number892.2050
Classification Product Code
QIH  
Date Received10/30/2024
Decision Date 05/28/2025
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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