ACCUSOFT, ACCUSOFT XL— 510(k) K062032

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K062032 for ACCUSOFT, ACCUSOFT XL, Substantially Equivalent on 2006-10-05. Applicant: Direx Systems Corp..

Clearance details

Applicant: Direx Systems Corp.
Product code: Code MUJ
Advisory panel: Radiology
Date received: 2006-07-18
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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