Company profile

iCAD, Inc.

iCAD, Inc. has 7 AI-enabled medical devices on the FDA list. The first decision was on January 31, 2002 and the most recent on November 8, 2024 (ProFound Detection (V4.0)). Its most common review panel is Radiology (7 devices).

7AI devices

2002First decision

2024Latest decision

1Specialties

Per year

200220172018201920212024

iCAD, Inc. AI devices per year: 2002 1, 2017 1, 2018 1, 2019 1, 2021 2, 2024 1

By specialty

Radiology7

Related guides

Top radiology devices

Timeline

November 8, 2024 · 510(k) K240417ProFound Detection (V4.0) · Radiology · QDQ
July 12, 2021 · 510(k) K211506PowerLook Density Assessment V4.0 · Radiology · QIH
March 12, 2021 · 510(k) K203822ProFound AI Software V3.0 · Radiology · QDQ
October 4, 2019 · 510(k) K191994ProFound AI Software V2.1 · Radiology · QDQ
December 6, 2018 · 510(k) K182373PowerLook Tomo Detection V2 Software · Radiology · QDQ
March 24, 2017 · PMA P160009PowerLook® Tomo Detection Software · Radiology · MYN
January 31, 2002 · PMA P010034SECOND LOOK ™ · Radiology · MYN