PCCR DIGITAL IMAGING DEVICE— 510(k) K003256

Name: FDA 510(k) clearance K003256
Creator: U.S. Food and Drug Administration
Published: 2000-11-08

Substantially Equivalent

Orex Computed Radiography, Ltd.

FDA 510(k) clearance K003256 for PCCR DIGITAL IMAGING DEVICE, Substantially Equivalent on 2000-11-08. Applicant: Orex Computed Radiography, Ltd.. Device class: 2.

Clearance details

Applicant: Orex Computed Radiography, Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2000-10-17
Decision date: 2000-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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