FDA applicant

Kodak Health Imaging Systems, Inc.

Dallas, TX6 decisions1995–19960 recalls

FDA records 6 decisions for Kodak Health Imaging Systems, Inc. (Dallas, TX) from 1995 to 1996: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMC (Camera, Multi Format, Radiological). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is 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 Kodak Health Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kodak Health Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Kodak”

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

Kodak-Trophy 1 Kodak Clinical Diagnostics, Ltd. 1

Kodak Health Imaging Systems, 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?

Other applicant names beginning “Kodak”