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510(k) K171461

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems by Philips Medical Systems Dmc GmbH — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2017
Date Received
May 18, 2017
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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