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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 Rd.
Northbrook,  IL  60062
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
Predetermined Change
Control Plan Authorized		 No
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