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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 K052305
Device Name MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
Applicant
Siemens Medical Solutions USA, Inc.
45 Stiles Rd.
Salem,  NH  03079
Applicant Contact BARRY V ASHAR
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA DANIELSON
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/24/2005
Decision Date 09/08/2005
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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