510(k) Report

FDA applicant

Icad, Inc.

Nashua, NH18 decisions2002–20242 recalls

FDA records 18 decisions for Icad, Inc. (Nashua, NH) from 2002 to 2024: 14 510(k) clearances and 4 original PMA approvals. Most are in product codes MYN (Analyzer, Medical Image) and QDQ (Radiological Computer Assisted…). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 139 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Icad, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12010: 12012: 22013: 22014: 12016: 12017: 12018: 22019: 12021: 22024: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Icad, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Icad, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MYNAnalyzer, Medical Image4decisions
  • QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For…4decisions
  • LLZSystem, Image Processing, Radiological4decisions
  • JADSystem, Therapeutic, X-Ray3decisions
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled1decision
  • QIHAutomated Radiological Image Processing Software1decision

Also: JAK (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 139 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 20132cite it
  • K180125PowerLook Density Assessment SoftwareIcad, Inc. · 20182cite it
  • K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 20182cite it
  • K042697Second Look ViewerIcad, Inc. · 20042cite it
  • K121517Versavue Enterprise SuiteIcad, Inc. · 20122cite it
  • K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 20161cites it

What has FDA decided for it lately?

  • K240417ProFound Detection (V4.0)Icad, Inc. · 2024
  • K211506PowerLook Density Assessment V4.0Icad, Inc. · 2021
  • K203822ProFound AI Software V3.0Icad, Inc. · 2021
  • K191994ProFound AI Software V2.1Icad, Inc. · 2019
  • K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018
  • K180125PowerLook Density Assessment SoftwareIcad, Inc. · 2018
  • P160009PowerLook® Tomo Detection SoftwareIcad, Inc. · 2017
  • K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016

All 18 as Icad, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K121517DynaCad software consist of an MR Analysis Server software and the viewer workstation…Jan 24, 2018Class II
  • K090223DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2Jan 21, 2015Class II