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510(k) K003256

PCCR DIGITAL IMAGING DEVICE by Orex Computed Radiography, Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2000
Date Received
October 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Orex Computed Radiography, Ltd.

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