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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 STREET,
SUZHOU INDUSTRIAL PARK
SUZHOU,  CN 215123
Applicant Contact LEILEI LI
Correspondent
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
A2-201/B3-501, BIOBAY, 218 XINGHU STREET,
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
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