FDA applicant

Cedara Software Corp.

Mississauga Ontario, CA5 decisions2000–20107 recalls

FDA records 5 decisions for Cedara Software Corp. (Mississauga Ontario, CA) from 2000 to 2010: 5 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 8 predicates, 3 of them its own earlier devices. 7 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 Cedara Software Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 3 (2016) · low 0 (2008)2026

Class I Class II/III not classified

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

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Cedara Software Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?