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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 K232436
Device Name Rapid SDH
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 Number892.2080
Classification Product Code
QAS  
Date Received08/14/2023
Decision Date 10/25/2023
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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