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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K221248
Device Name Rapid LVO
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 Number892.2080
Classification Product Code
QAS  
Date Received05/02/2022
Decision Date 05/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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