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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 K153058
Device Name CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
Applicant
Careray Digital Medical System Co., Ltd.
A2-201/B3-501, Biobay 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215123
Applicant Contact LEILEI LI
Correspondent
Careray Digital Medical System Co., Ltd.
A2-201/B3-501, Biobay 218 Xinghu St.,
Suzhou Industrial Park
Suzhou,  CN 215123
Correspondent Contact LEILEI LI
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/21/2015
Decision Date 11/10/2015
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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