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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 K931008
Device Name MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL
Applicant
Mri Devices Corp.
1900 Pewaukee Rd., Suite N
Airport Business Center
Waukesha,  WI  53188
Applicant Contact THOMAS SCHUBERT
Correspondent
Mri Devices Corp.
1900 Pewaukee Rd., Suite N
Airport Business Center
Waukesha,  WI  53188
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received02/26/1993
Decision Date 06/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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