FDR D-EVO II FLAT PANEL DETECTOR SYSTEM

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

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 Fdr D-evo Ii Flat Panel Detector System.

Pre-market Notification Details

• Device ID: K142003
• 510k Number: K142003
• Device Name: FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
• Classification: Solid State X-ray Imager (flat Panel/digital Imager)
• Applicant: FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300
• Contact: Katherine Y Choi
• Correspondent: Katherine Y Choi; FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300
• Product Code: MQB
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-23
• Decision Date: 2014-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04547410530582	K142003	000
04547410549294	K142003	000
04547410549300	K142003	000
04547410288803	K142003	000
04547410288858	K142003	000
04547410288902	K142003	000
04547410288957	K142003	000
04547410288971	K142003	000
04547410288995	K142003	000
04547410289015	K142003	000
04547410289039	K142003	000
04547410549287	K142003	000
04547410549270	K142003	000
04547410530599	K142003	000
04547410530605	K142003	000
04547410530612	K142003	000
04547410530629	K142003	000
04547410530636	K142003	000
04547410530643	K142003	000
04547410530650	K142003	000
04547410530667	K142003	000
04547410545883	K142003	000
04547410549263	K142003	000
04547410289053	K142003	000
04547410289077	K142003	000
04547410290851	K142003	000
04547410333374	K142003	000
04547410335286	K142003	000
04547410355406	K142003	000
04547410361346	K142003	000
04547410361353	K142003	000
04547410361360	K142003	000
04547410361377	K142003	000
04547410431599	K142003	000
04547410438352	K142003	000
04547410448214	K142003	000
04547410319385	K142003	000
04547410309324	K142003	000
04547410290899	K142003	000
04547410305067	K142003	000
04547410308211	K142003	000
04547410308501	K142003	000
04547410308518	K142003	000
04547410308525	K142003	000
04547410308532	K142003	000
04547410308549	K142003	000
04547410309249	K142003	000
04547410309294	K142003	000
04547410355420	K142003	000