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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K013218
Device Name FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Applicant Contact JOSEPH M AZARY
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902
Correspondent Contact JOSEPH M AZARY
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/26/2001
Decision Date 12/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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