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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 K221456
Device Name Rapid ICH
Applicant
iSchemaView Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Applicant Contact James Rosa
Correspondent
iSchemaView Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Correspondent Contact James Rosa
Regulation Number892.2080
Classification Product Code
QAS  
Date Received05/19/2022
Decision Date 09/12/2022
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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