COMMUNIFY PACS VIEWER— 510(k) K110797

Substantially Equivalent

Flying Squirrel Storage, LLC

FDA 510(k) clearance K110797 for COMMUNIFY PACS VIEWER, Substantially Equivalent on 2011-07-20. Applicant: Flying Squirrel Storage, LLC.

Clearance details

Applicant
Flying Squirrel Storage, LLC
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New York, NY, 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.