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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 K962138
Device Name FLEXART V3.1 SOFTWARE
Applicant
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Applicant Contact JAVAD SEYEDZADEH
Correspondent
TOSHIBA AMERICA MRI, INC.
280 UTAH AVE.
SOUTH SAN FRANCISCO,  CA  94080 -6883
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/03/1996
Decision Date 12/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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