FDA applicant

Emageon, Inc.

Madison, WI2 decisions2005–200820 recalls

FDA records 2 decisions for Emageon, Inc. (Madison, WI) from 2005 to 2008: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQK (Computer, Diagnostic, Programmable). Its devices cite 3 predicates, 0 of them its own earlier devices. 20 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 Emageon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

8in 2016

2007high 8 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Emageon, 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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Other applicant names beginning “Emageon”

FDA records each applicant name separately; these may or may not be the same firm.

Emageon Uv, Inc. 1

Emageon, Inc.

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?

Other applicant names beginning “Emageon”