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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 K161966
Device Name PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
Applicant
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Applicant Contact Dawn Spooner
Correspondent
Perkinelmer, Inc.
940 Winter St.
Waltham,  MA  02451
Correspondent Contact Dawn Spooner
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/18/2016
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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