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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K223396
Device Name Rapid RV/LV
Applicant
iSchema View Inc.
1120 Washington Ave., Ste 200
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
QIH  
Date Received11/08/2022
Decision Date 02/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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