MODIFICATION TO ACCULEAF— 510(k) K040553

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K040553 for MODIFICATION TO ACCULEAF, Substantially Equivalent on 2004-04-01. Applicant: Direx Systems Corp.. Device class: 2.

Clearance details

Applicant: Direx Systems Corp.
Product code: Code IXI
Device class: Class 2
Regulation: 21 CFR 892.5710
Advisory panel: Radiology
Date received: 2004-03-02
Decision date: 2004-04-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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