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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 K150929
Device Name CareView 1500Cw X-ray Flat Panel Detectors
Applicant
Careray Digital Medical System Co., Ltd.
A2-201/B3-501, Biobay, 218 Xinghu St.
Quality Dept.
Sunzhou,  CN 215123
Applicant Contact YULING DING
Correspondent
Careray Digital Medical System Co., Ltd.
A2-201/B3-501, Biobay, 218 Xinghu St.
Quality Dept.
Sunzhou,  CN 215123
Correspondent Contact YULING DING
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/06/2015
Decision Date 08/04/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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