510(k) Report

FDA applicant

3tp, LLC

White Plains, NY2 decisions2003–20051 recall

FDA records 2 decisions for 3tp, LLC (White Plains, NY) from 2003 to 2005: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 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 3tp, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 3tp, LLC since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — 3tp, LLC 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
  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K0313503TP Software Option3tp, LLC · 20033cite it
  • K0508623TP Workspace3tp, LLC · 20051cites it

What has FDA decided for it lately?

  • K0508623TP Workspace3tp, LLC · 20051 recall
  • K0313503TP Software Option3tp, LLC · 20031 recall

All 2 as 3tp, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K031350CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment…Dec 9, 2008