510(k) Report

FDA applicant

Visualization Technology, Inc.

North Attleboro, MA7 decisions1996–200116 recalls

FDA records 7 decisions for Visualization Technology, Inc. (North Attleboro, MA) from 1996 to 2001: 7 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 15 predicates, 10 of them its own earlier devices. 16 recalls are linked to its devices, 2 Class I.

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 Visualization Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Visualization Technology, Inc. since 2007.

Recalls per year

1in 2013

2007: 3, 1 Class I2009: 1, 1 Class I2013: 1
2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Visualization Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological7decisions

Whose devices does it build on?

Its devices cite 15 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 23 times; 10 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.

  • K960330InstatrakVisualization Technology, Inc. · 19968cite it
  • K983529Instatrak 3000Visualization Technology, Inc. · 19985cite it
  • K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 19984cite it
  • K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 20003cite it
  • K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 19982cite it
  • K003510Instatrak System with Fluorocat, Model IT3500Visualization Technology, Inc. · 20011cites it

What has FDA decided for it lately?

  • K003510Instatrak System with Fluorocat, Model IT3500Visualization Technology, Inc. · 20012 recalls
  • K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 20002 Class I recalls
  • K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight…Visualization Technology, Inc. · 19991 Class I recall
  • K983529Instatrak 3000Visualization Technology, Inc. · 19981 Class I recall
  • K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 19981 Class I recall
  • K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 19981 Class I recall
  • K960330InstatrakVisualization Technology, Inc. · 19961 Class I recall

All 7 as Visualization Technology, Inc. →

What has been recalled?

16 recalls linked to its devices; the latest:

  • K960330InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted…Nov 26, 2013Class II
  • K960330OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus…Jun 22, 2009Class I
  • K960330GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE…Oct 18, 2007
  • K960330Cleaning probe included as an accessory to aspirators that are sterile packed single use…May 18, 2007
  • K994270Radiological Image Processing System The system is an aid to locate anatomical…Apr 2, 2007Class I
  • K003510OEC InstaTrak 3500, picture archiving and communications system intended as an aid to…Oct 11, 2006Class II