EZPACS, VERSION 3.0— 510(k) K062878

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.

Clearance details

Applicant
Advanced Imaging Solutions, LLC
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Lancaster, CA, US
Download summary PDFView on FDA.gov ↗

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 →

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