FUJI IP CASSETTE TYPE PC

Accelerator, Linear, Medical

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

The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fuji Ip Cassette Type Pc.

Pre-market Notification Details

Device IDK070920
510k NumberK070920
Device Name:FUJI IP CASSETTE TYPE PC
ClassificationAccelerator, Linear, Medical
Applicant FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
ContactDebbie Peacock
CorrespondentDebbie Peacock
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford,  CT  06902 -6300
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-02
Decision Date2007-05-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14547410050001 K070920 000
14547410049722 K070920 000
14547410049739 K070920 000
14547410343790 K070920 000
14547410343806 K070920 000
14547410049708 K070920 000
14547410049715 K070920 000
14547410049982 K070920 000
14547410049999 K070920 000
04547410049213 K070920 000

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