FDA applicant

Fischer Imaging Corp.

Denver, CO69 decisions1981–20047 recalls

FDA records 69 decisions for Fischer Imaging Corp. (Denver, CO) from 1981 to 2004: 69 510(k) clearances. Most are in product codes IZO (Generator, High-Voltage, X-Ray, Diagnostic) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). 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 Fischer Imaging Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fischer Imaging Corp. since 2007.

Recalls per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Fischer Imaging Corp.’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 “Fischer”

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

Fischer Industries, Inc. 3 Fischer-Zoth Audiologic Systems, Inc. 2 Fischer Medical 1 Fischer Medical Technologies, Inc. 1 Fischer Surgical, Inc. 1

Fischer Imaging Corp.

Which product codes does it file in?

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 “Fischer”