510(k) Report

FDA applicant

Brit Systems, Inc.

Dallas, TX2 decisions1994–20090 recalls

FDA records 2 decisions for Brit Systems, Inc. (Dallas, TX) from 1994 to 2009: 2 510(k) clearances. Most are in product codes LMD (System, Digital Image Communications…) and LLZ (System, Image Processing, Radiological). Its devices cite 2 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 Brit Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LMDSystem, Digital Image Communications, Radiological1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K943383Imaging WorkbenchBrit Systems, Inc. · 19941cites it

What has FDA decided for it lately?

  • K081168Brit Pacs SystemsBrit Systems, Inc. · 2009
  • K943383Imaging WorkbenchBrit Systems, Inc. · 1994

All 2 as Brit Systems, Inc. →