510(k) Report

FDA applicant

Olicon Imaging Systems, Inc.

Plano, TX3 decisions1993–19970 recalls

FDA records 3 decisions for Olicon Imaging Systems, Inc. (Plano, TX) from 1993 to 1997: 3 510(k) clearances. All are in product code LMD (System, Digital Image Communications…). Its devices cite 2 predicates, 1 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 Olicon Imaging Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Olicon Imaging Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Olicon Imaging 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, Radiological3decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 1 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.

  • K973959Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 19976cite it
  • K922164Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 19934cite it

What has FDA decided for it lately?

  • K973959Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
  • K973793Olicon Imaging Systems, Inc. Gateway and/or SoftwareOlicon Imaging Systems, Inc. · 1997
  • K922164Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993

All 3 as Olicon Imaging Systems, Inc. →