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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K160984
Device Name MultiScan G-Arm System
Applicant
Beijing East Whale Imaging Technology Co., Ltd.
B2-2 New City Industrial Park,
#9 Kechuang 2nd St. Yizhuang
Beijing,  CN 100023
Applicant Contact SHARON FAN
Correspondent
Beijing East Whale Imaging Technology Co., Ltd.
B2-2 New City Industrial Park,
#9 Kechuang 2nd St. Yizhuang
Beijing,  CN 100023
Correspondent Contact SHARON FAN
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received04/07/2016
Decision Date 07/20/2016
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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