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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K001303
Device Name BREAST IMMOBILIZATION DEVICE MR-BY 160
Applicant
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Applicant Contact THOMAS SCHUBERT
Correspondent
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Correspondent Contact THOMAS SCHUBERT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received04/24/2000
Decision Date 06/20/2000
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
Recalls CDRH Recalls
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