510(k) Report

FDA applicant

Tripath Imaging, Inc.

Durham, NC5 decisions2005–20071 recall

FDA records 5 decisions for Tripath Imaging, Inc. (Durham, NC) from 2005 to 2007: 5 510(k) clearances. Most are in product codes NQN (Microscope, Automated, Image Analysis…) and NOT (Microscope, Automated, Image Analysis…). 1 recall is linked to its devices.

FDA’s records also spell it “Tripath Imaging”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Tripath Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Tripath Imaging, 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?

  • NQNMicroscope, Automated, Image Analysis, Immunohistochemistry,Operator…4decisions
  • NOTMicroscope, Automated, Image Analysis, Operator Intervention1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K062428Ventana Image Analysis System, Model ViasTripath Imaging, Inc. · 20061cites it
  • K053520Ventana Image Analysis System, Model KI-67Tripath Imaging, Inc. · 20061cites it

What has FDA decided for it lately?

  • K061613Ventana Image Analysis System - Pathway HER2 (4B5)Tripath Imaging · 20071 recall
  • K062428Ventana Image Analysis System, Model ViasTripath Imaging, Inc. · 2006
  • K053520Ventana Image Analysis System, Model KI-67Tripath Imaging, Inc. · 2006
  • K051282Ventana Image Analysis System - HER2/NeuTripath Imaging, Inc. · 2005
  • K050012Ventana Image Analysis SystemTripath Imaging, Inc. · 2005

All 4 as Tripath Imaging, Inc. →The one decision as Tripath Imaging →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061613Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody…Jun 26, 2007