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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 K091669
Device Name OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
Applicant
XIOAO MDT TECHNOLOGY CO LTD
UNDERWRITERS LABORATORIES, INC
333 PFINGSTEN ROAD
NORTHBROOK,  IL  60062 -2096
Applicant Contact Diana Hong
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/09/2009
Decision Date 06/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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