CROSSPLAN / ACCUSOFT-XL V.4.04— 510(k) K063482

Name: FDA 510(k) clearance K063482
Creator: U.S. Food and Drug Administration
Published: 2006-12-14

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K063482 for CROSSPLAN / ACCUSOFT-XL V.4.04, Substantially Equivalent on 2006-12-14. Applicant: Direx Systems Corp.. Device class: 2.

Clearance details

Applicant: Direx Systems Corp.
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2006-11-17
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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