POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE— 510(k) K052460

Substantially Equivalent

Ramsoft, Inc.

FDA 510(k) clearance K052460 for POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE, Substantially Equivalent on 2005-09-21. Applicant: Ramsoft, Inc..

Clearance details

Applicant
Ramsoft, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, CA
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.