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510(k) K112132

KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM by Medicatech USA — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2011
Date Received
July 26, 2011
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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