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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K970349
Device Name FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
Applicant
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Applicant Contact ROBERT A UZENOFF
Correspondent
Fujifilm Medical System U.S.A., Inc.
333 Ludlow St.
P.O. Box 120035
Stamford,  CT  06912
Correspondent Contact ROBERT A UZENOFF
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/30/1997
Decision Date 03/31/1997
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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