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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cabinet, X-Ray System
510(k) Number K202713
Device Name TrueView 100 Pro
Applicant
Compai Healthcare (Shenzhen) Co.,Ltd
8b, Huangting Bldg., #355, Fuhua Rd., Futian St.,
Futian District
Shenzhen,  CN 518026
Applicant Contact Wang Yan
Correspondent
Compai Healthcare (Shenzhen) Co.,Ltd
8b, Huangting Bldg., #355, Fuhua Rd., Futian St.,
Futian District
Shenzhen,  CN 518026
Correspondent Contact Wang Yan
Regulation Number892.1680
Classification Product Code
MWP  
Date Received09/16/2020
Decision Date 11/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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