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510(k) K081963

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS by Agfa Healthcare Corporation — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2008
Date Received
July 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Agfa Healthcare Corporation

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  • K072680 — DRYSTAR AXYS, MODEL EYZ4E (October 25, 2007)

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