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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K024188
Device Name UP-DF500 FILMSTATION DIGITAL FILM IMAGER
Applicant
Sony Medical Systems
C/O Medical Device Consult,Inc
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Sony Medical Systems
C/O Medical Device Consult,Inc
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number892.2040
Classification Product Code
LMC  
Date Received12/19/2002
Decision Date 02/04/2003
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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