Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list iCAD with 14 510(k) clearances, 7 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Nov 8, 2024: ProFound Detection (V4.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 8, 2024 | ProFound Detection (V4.0)K240417 · QDQ | 510(k) clearances |
| Nov 8, 2024 | ProFound Detection (V4.0)K240417 · Radiology | AI-enabled devices |
| Jul 12, 2021 | PowerLook Density Assessment V4.0K211506 · QIH | 510(k) clearances |
| Jul 12, 2021 | PowerLook Density Assessment V4.0K211506 · Radiology | AI-enabled devices |
| Mar 12, 2021 | ProFound AI Software V3.0K203822 · QDQ | 510(k) clearances |
| Mar 12, 2021 | ProFound AI Software V3.0K203822 · Radiology | AI-enabled devices |
| Oct 4, 2019 | ProFound AI Software V2.1K191994 · QDQ | 510(k) clearances |
| Oct 4, 2019 | ProFound AI Software V2.1K191994 · Radiology | AI-enabled devices |
| Dec 6, 2018 | PowerLook Tomo Detection V2 SoftwareK182373 · QDQ | 510(k) clearances |
| Dec 6, 2018 | PowerLook Tomo Detection V2 SoftwareK182373 · Radiology | AI-enabled devices |
| Apr 5, 2018 | PowerLook Density Assessment SoftwareK180125 · LLZ | 510(k) clearances |
| Mar 24, 2017 | PowerLook® Tomo Detection SoftwareP160009 · Radiology | AI-enabled devices |
| Feb 25, 2016 | Axxent Electronic Brachytherapy System Model 110 XP 1200K153570 · JAD | 510(k) clearances |
| Jan 21, 2015 | DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2Class II · A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiograph | Device recalls |
| Sep 5, 2014 | AXXENT CERVICAL APPLICATORK141343 · JAD | 510(k) clearances |
| Jan 31, 2002 | SECOND LOOK ™P010034 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
