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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 K181526
Device Name XRpad2 4343 HWC-M Flat Panel Detector
Applicant
Varex Imaging Corporation
2175 Mission College Blvd.
Santa Clara,  CA  95054
Applicant Contact Paul Sawicki
Correspondent
Varex Imaging Corporation
2175 Mission College Blvd.
Santa Clara,  CA  95054
Correspondent Contact Paul Sawicki
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/11/2018
Decision Date 07/03/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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