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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K232156
Device Name Rapid ASPECTS (v3)
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 Number892.2060
Classification Product Code
POK  
Date Received07/20/2023
Decision Date 01/19/2024
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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