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510(k) K073670

KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 by Orex Computed Radiography, Ltd. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2008
Date Received
December 27, 2007
Clearance Type
Special
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.

  • K032654 — PORT CASSETTE (October 9, 2003)
  • K003256 — PCCR DIGITAL IMAGING DEVICE (November 8, 2000)

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