VOYAGER PACS SYSTEM— 510(k) K062062

Substantially Equivalent

Voyager Imaging

FDA 510(k) clearance K062062 for VOYAGER PACS SYSTEM, Substantially Equivalent on 2006-09-11. Applicant: Voyager Imaging.

Clearance details

Applicant
Voyager Imaging
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Denton, TX, 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.