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510(k) K181526

XRpad2 4343 HWC-M Flat Panel Detector by Varex Imaging Corporation — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2018
Date Received
June 11, 2018
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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