INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000— 510(k) K994270

Substantially Equivalent

Visualization 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..

Clearance details

Applicant: Visualization Technology, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1999-12-20
Decision date: 2000-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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Adverse events under product code LLZ

product code LLZ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.