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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 K233512
Device Name Rapid (6.0)
Applicant
iSchemaView, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Applicant Contact Jim Rosa
Correspondent
iSchemaView, Inc.
1120 Washington Ave.
Suite 200
Golden,  CO  80401
Correspondent Contact Jim Rosa
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received11/01/2023
Decision Date 01/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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