510(k) K162909

CSX-30 Flat Panel Detector by Canon, Inc. – Medical Equipment Group — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2017
Date Received
October 17, 2016
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