INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000— 510(k) K994270
Substantially EquivalentVisualization Technology, Inc.
FDA 510(k) clearance K994270 for INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000, Substantially Equivalent on 2000-03-09. 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
- Wilmington, MA, US
Recent devices under product code LLZ
view allMore clearances from Visualization Technology, Inc.
view allAdverse 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 K994270
K-number listed on FDA's recall record- 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.
- Z-2136-2012 — Radiological Image Processing System The system is an aid to locate anatomical structures during open or 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 CS, MR, or X-ray.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994270.
Data sourced from openFDA. This site is unofficial and independent of the FDA.