INSTATRAK— 510(k) K960330
Substantially EquivalentVisualization Technology, Inc.
FDA 510(k) clearance K960330 for INSTATRAK, Substantially Equivalent on 1996-04-08. Applicant: Visualization Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Visualization Technology, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woburn, MA, US
Recent devices under product code LLZ
view allMore clearances from Visualization Technology, Inc.
view all- K003510 — INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
- K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
- K990919 — STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
- K983529 — INSTATRAK 3000
- K982994 — SKULL BASE INSTATRAK SYSTEM
Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K960330
K-number listed on FDA's recall record- Z-0524-2014 — InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
- Z-2251-2012 — OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960330.
Data sourced from openFDA. This site is unofficial and independent of the FDA.