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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K182683
Device Name Z-Robot Patient Positioning System
Applicant
Chinan Biomedical Technology, Inc.
6f., #16, Sec.2 , Shengyi Rd., Zhubei City
Hsinchu County,  TW 302
Applicant Contact James Chinan Chen
Correspondent
Chinan Biomedical Technology, Inc.
6f., #16, Sec.2 , Shengyi Rd., Zhubei City
Hsinchu County,  TW 302
Correspondent Contact James Chinan Chen
Regulation Number892.5770
Classification Product Code
JAI  
Date Received09/26/2018
Decision Date 06/27/2019
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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