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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K042948
Device Name I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
Applicant
WANDONG MEDICAL
NO. 7 SANJIANFANG NANLI
CHAOYANG DISTRICT
BEIJING,  CN 100024
Applicant Contact WANG WEIMIN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/26/2004
Decision Date 11/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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