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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
Device Name PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
Applicant
PERKINELMER, INC.
8275 CARLOWAY ROAD
INDIANAPOLIS,  IN  46236
Applicant Contact KAY A TAYLOR
Correspondent
PERKINELMER, INC.
8275 CARLOWAY ROAD
INDIANAPOLIS,  IN  46236
Correspondent Contact KAY A TAYLOR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/16/2012
Decision Date 11/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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