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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 K942953
Device Name ORACLE MRI WHOLE BODY MR IMAGING SYSTEM
Applicant
Otsuka Electronics USA, Inc.
2555 Midpoint Dr.
Fort Collins,  CO  80525
Applicant Contact G. NEIL HOLLAND
Correspondent
Otsuka Electronics USA, Inc.
2555 Midpoint Dr.
Fort Collins,  CO  80525
Correspondent Contact G. NEIL HOLLAND
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/22/1994
Decision Date 09/30/1994
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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