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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K122495
Model XRD 1622 AP# MED
Device Name PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
Original Applicant
PERKINELMER, INC.
8275 carloway road
indianapolis,  IN  46236
Original Contact kay a taylor
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/16/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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