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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K213165
Device Name Rapid
Applicant
iSchema View Inc.
433 Park Point Drive, Suite 220
Golden,  CO  80401
Applicant Contact James Rosa
Correspondent
iSchema View Inc.
433 Park Point Drive, Suite 220
Golden,  CO  80401
Correspondent Contact James Rosa
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
QIH  
Date Received09/28/2021
Decision Date 02/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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