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510(k) K112670

DX-D 600 by Agfa Healthcare N.V. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2011
Date Received
September 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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