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510(k) K012750

ADC PEDIATRIC by Agfa Corp. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2001
Date Received
August 16, 2001
Clearance Type
Traditional
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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