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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 K041286
Device Name DYNACAD V1.0
Applicant
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Applicant Contact TOM TYNES
Correspondent
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Correspondent Contact TOM TYNES
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received05/13/2004
Decision Date 07/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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