510(k) Report

FDA applicant

3Dsharp, Inc.

Pittsburgh, PA1 decision2002–20020 recalls

FDA records 1 decision for 3Dsharp, Inc. (Pittsburgh, PA) in 2002: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 3Dsharp, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3Dsharp, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3Dsharp, 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?

  • LLZSystem, Image Processing, Radiological1decision

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.

  • K0138413DFIS, Model Ies-FL-1013Dsharp, Inc. · 20021cites it

What has FDA decided for it lately?

  • K0138413DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002

The one decision as 3Dsharp, Inc. →