PORT CASSETTE— 510(k) K032654

Substantially Equivalent

Orex Computed Radiography, Ltd.

FDA 510(k) clearance K032654 for PORT CASSETTE, Substantially Equivalent on 2003-10-09. Applicant: Orex Computed Radiography, Ltd.. Device class: 2.

Clearance details

Applicant: Orex Computed Radiography, Ltd.
Product code: Code IXK
Device class: Class 2
Regulation: 21 CFR 892.1630
Advisory panel: Radiology
Date received: 2003-08-28
Decision date: 2003-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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