INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500— 510(k) K003510

Clearance details

Applicant

Visualization Technology, Inc.

Product code

Code LLZ

Device class

Class 2

Regulation

21 CFR 892.2050

Advisory panel

Radiology

Date received

2000-11-14

Decision date

2001-02-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, MA, US

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• K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT30002000-03-09
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• K981998 — PEDIATRIC INSTATRAK SYSTEM1998-08-21

Death

13

Total

13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2236-2012 — OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.Class II·Terminated·GE OEC Medical Systems, Inc·20061011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003510.