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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 STREET
QUALITY DEPARTMENT
SUNZHOU,  CN 215123
Applicant Contact YULING DING
Correspondent
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
A2-201/B3-501, BIOBAY, 218 XINGHU STREET
QUALITY DEPARTMENT
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
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