510(k) K140551

PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR by Perkinelmer, Inc. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2014
Date Received
March 4, 2014
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