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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,
NO.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,
NO.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
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