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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 K200760
Device Name Rapid ASPECTS
Applicant
iSchemaView Inc.
433 Park Point Drive, Suite 220
golden,  CO  80401
Applicant Contact jim rosa
Correspondent
iSchemaView Inc.
433 Park Point Drive, Suite 220
golden,  CO  80401
Correspondent Contact jim rosa
Regulation Number892.2060
Classification Product Code
POK  
Date Received03/24/2020
Decision Date 06/26/2020
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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