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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 K203822
Device Name ProFound AI Software V3.0
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 Received12/29/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No