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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 K230140
Device Name TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
Applicant
Compai Healthcare (Suzhou) Co.,Ltd
Rm. 3a05, Bldg. 2, #8 Changting Rd., High-Tech Zone
Suzhou,  CN 215151
Applicant Contact Xueqiao Wang
Correspondent
Compai Healthcare (Suzhou) Co.,Ltd
Rm. 3a05, Bldg. 2, #8 Changting Rd., High-Tech Zone
Suzhou,  CN 215151
Correspondent Contact Xueqiao Wang
Regulation Number892.1680
Classification Product Code
MWP  
Date Received01/18/2023
Decision Date 04/24/2023
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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