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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 K193173
Device Name CareView 1800Le
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 Received11/18/2019
Decision Date 12/13/2019
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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