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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
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