VISION TOOLS— 510(k) K090668

Substantially Equivalent

Millensys

FDA 510(k) clearance K090668 for VISION TOOLS, Substantially Equivalent on 2009-06-23. Applicant: Millensys.

Clearance details

Applicant: Millensys
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-03-13
Decision date: 2009-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blairstown, NJ, US

Download summary PDF View on FDA.gov ↗

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.