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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 detection/diagnosis software for lesions suspicious for cancer
510(k) Number K191994
Device Name ProFound AI Software V2.1
iCAD Inc.
98 Spit Brook Rd.
Suite 100
Nashua,  NH  03062
Applicant Contact Heather Reed
iCAD Inc.
98 Spit Brook Rd.
Suite 100
Nashua,  NH  03062
Correspondent Contact Heather Reed
Regulation Number892.2090
Classification Product Code
Date Received07/26/2019
Decision Date 10/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No