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510(k) K122842

RADREX-I, SW V4.00 MODEL DRAD-3000E by Toshiba America Medical Systems, In.C — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2012
Date Received
September 17, 2012
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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