510(k) K033377

FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L by Fujifilm Medical System U.S.A., Inc. — Product Code LMC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2004
Date Received
October 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Multi Format, Radiological
Device Class
Class II
Regulation Number
892.2040
Review Panel
RA
Submission Type