510(k) Report

FDA applicant

Efilm Medical, Inc.

Toronto, Ontario, CA3 decisions2001–20022 recalls

FDA records 3 decisions for Efilm Medical, Inc. (Toronto, Ontario, CA) from 2001 to 2002: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMA (Digitizer, Image, Radiological). Its devices cite 3 predicates, 1 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 Efilm Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Efilm Medical, Inc. since 2007.

Recalls per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions
  • LMADigitizer, Image, Radiological1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 1 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.

  • K020995Efilm Workstation with ModulesEfilm Medical, Inc. · 200215cite it
  • K012211Efilm WorkstationEfilm Medical, Inc. · 20018cite it

What has FDA decided for it lately?

  • K020995Efilm Workstation with ModulesEfilm Medical, Inc. · 20022 recalls
  • K013631Efilm VideoEfilm Medical, Inc. · 2001
  • K012211Efilm WorkstationEfilm Medical, Inc. · 20011 recall

All 3 as Efilm Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K020995Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software…Oct 20, 2016Class II
  • K012211eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS…Aug 28, 2014Class II