510(k) Report

FDA applicant

Intelerad Medical Systems Incorporated

Montreal, CA5 decisions2003–20206 recalls

FDA records 5 decisions for Intelerad Medical Systems Incorporated (Montreal, CA) from 2003 to 2020: 5 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 6 predicates, 3 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “Intelerad Medical Systems, Inc.”.

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 Intelerad Medical Systems Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12009: 12015: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 22014: 12025: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological5decisions

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K032533IntelepacsIntelerad Medical Systems, Inc. · 20032cite it
  • K150707IntelePACSIntelerad Medical Systems Incorporated · 20152cite it
  • K070080IntelepacsIntelerad Medical Systems, Inc. · 20071cites it
  • K083520Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 20091cites it

What has FDA decided for it lately?

  • K192176IntelePACSIntelerad Medical Systems Incorporated · 20203 recalls
  • K150707IntelePACSIntelerad Medical Systems Incorporated · 2015
  • K083520Intelepacs, Model Version 3.X.XIntelerad Medical Systems Incorporated · 20091 recall
  • K070080IntelepacsIntelerad Medical Systems, Inc. · 20072 recalls
  • K032533IntelepacsIntelerad Medical Systems, Inc. · 2003

All 3 as Intelerad Medical Systems Incorporated →All 2 as Intelerad Medical Systems, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K192176IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93…Sep 5, 2026Class II
  • K192176IntelePACS - InteleConnect / TechPortalOct 17, 2025Class II
  • K192176IntelePACS (Image Fusion Module) - InteleViewerFeb 5, 2025Class II
  • K083520IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that…Jul 3, 2014Class II
  • K070080IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.Oct 27, 2008
  • K070080IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.Oct 27, 2008