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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 K222884
Device Name Rapid NCCT Stroke
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 Received09/22/2022
Decision Date 03/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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