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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
Room 3A05, Building 2, No.8 Changting Road, High-tech Zone
Suzhou,  CN 215151
Applicant Contact Xueqiao Wang
Correspondent
CompAI Healthcare (Suzhou) Co.,ltd
Room 3A05, Building 2, No.8 Changting Road, 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
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