EZPACS, VERSION 3.0— 510(k) K062878

Name: FDA 510(k) clearance K062878
Creator: U.S. Food and Drug Administration
Published: 2007-06-27

Substantially Equivalent

Advanced Imaging Solutions, LLC

FDA 510(k) clearance K062878 for EZPACS, VERSION 3.0, Substantially Equivalent on 2007-06-27. Applicant: Advanced Imaging Solutions, LLC. Device class: 2.

Clearance details

Applicant: Advanced Imaging Solutions, LLC
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-09-26
Decision date: 2007-06-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Lancaster, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

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.