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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 prioritization software for lesions
510(k) Number K230074
Device Name Rapid Aneurysm Triage and Notification
Applicant
iSchemaView Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Applicant Contact James Rosa
Correspondent
iSchemaView Inc.
1120 Washington Ave., Ste 200
Golden,  CO  80401
Correspondent Contact James Rosa
Regulation Number892.2080
Classification Product Code
QFM  
Date Received01/10/2023
Decision Date 07/27/2023
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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