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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 K925858
Device Name OE 1.5 SI
Applicant
Otsuka Electronics
2555 Midpoint Dr.
Fort Collins,  CO  80525
Applicant Contact JEAN M MACHELEDT
Correspondent
Otsuka Electronics
2555 Midpoint Dr.
Fort Collins,  CO  80525
Correspondent Contact JEAN M MACHELEDT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/17/1992
Decision Date 12/02/1993
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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