iCAD Inc.

7 AI-enabled medical devices from iCAD Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2024-11-08K240417ProFound Detection (V4.0)iCAD, Inc.Radiology
2021-07-12K211506PowerLook Density Assessment V4.0iCAD, Inc.Radiology
2021-03-12K203822ProFound AI Software V3.0iCAD Inc.Radiology
2019-10-04K191994ProFound AI Software V2.1iCAD Inc.Radiology
2018-12-06K182373PowerLook Tomo Detection V2 SoftwareiCAD Inc.Radiology
2017-03-24P160009PowerLook® Tomo Detection SoftwareiCAD IncRadiology
2002-01-31P010034SECOND LOOK ™ICAD, INC.Radiology

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