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510(k) K053634

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION by Agfa Corporation — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2006
Date Received
December 29, 2005
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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