FUJIFILM EC-B SERIES CASETTE

Cassette, Radiographic Film

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Ec-b Series Casette.

Pre-market Notification Details

Device IDK932565
510k NumberK932565
Device Name:FUJIFILM EC-B SERIES CASETTE
ClassificationCassette, Radiographic Film
Applicant FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford,  CT  06912 -0035
ContactRobert Uzenoff
CorrespondentRobert Uzenoff
FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford,  CT  06912 -0035
Product CodeIXA  
CFR Regulation Number892.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-27
Decision Date1993-07-26

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