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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 K200941
Device Name Rapid LVO
Applicant
iSchemaView Inc.
433 Park Point Drive, Suite 220
Golden,  CO  80401
Applicant Contact Jim Rosa
Correspondent
iSchemaView Inc.
433 Park Point Drive, Suite 220
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/08/2020
Decision Date 07/09/2020
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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