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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 K981898
Device Name ORTHOVU-1000
Applicant
Magnevu
2225 Faraday Ave.
Suite F
Carlsbad,  CA  92008
Applicant Contact BOB ROSE
Correspondent
Magnevu
2225 Faraday Ave.
Suite F
Carlsbad,  CA  92008
Correspondent Contact BOB ROSE
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/01/1998
Decision Date 08/03/1998
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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