ProFound AI Software V3.0

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

ICAD Inc.

The following data is part of a premarket notification filed by Icad Inc. with the FDA for Profound Ai Software V3.0.

Pre-market Notification Details

Device IDK203822
510k NumberK203822
Device Name:ProFound AI Software V3.0
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua,  NH  03062
ContactHeather Reed
CorrespondentHeather Reed
iCAD Inc. 98 Spit Brook Rd. Suite 100 Nashua,  NH  03062
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-29
Decision Date2021-03-12

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