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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 K052315
Device Name SIMTEC IM-MAXX 2 OPTION
Applicant
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Applicant Contact CHRISTINE DUNBAR
Correspondent
Siemens Medical Solutions USA, Inc.
4040 Nelson Ave.
Concord,  CA  94520
Correspondent Contact CHRISTINE DUNBAR
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/25/2005
Decision Date 09/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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