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510(k) K062742

CR 85-X by Agfa Corporation — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2006
Date Received
September 14, 2006
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

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