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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 K093427
Device Name FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Applicant Contact DEBBIE PEACOCK
Correspondent
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
419 WEST AVE.
STAMFORD,  CT  06902 -6300
Correspondent Contact DEBBIE PEACOCK
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/03/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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