DR-ID 1200SDK System

Solid State X-ray Imager (flat Panel/digital Imager)

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Dr-id 1200sdk System.

Pre-market Notification Details

Device IDK200668
510k NumberK200668
Device Name:DR-ID 1200SDK System
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentKamila Sak
FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-13
Decision Date2020-04-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410436723 K200668 000
04547410436716 K200668 000
04547410436709 K200668 000
04547410436693 K200668 000
04547410436686 K200668 000

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