510(k) · Cleared

Cleared

Wireless/Wired FDR D-Evo Flat Panel Detector

K103596510(k) SpecialCleared Mar 29, 2011111-day reviewClass II21 CFR 892.1680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujifilm Medical Systems U.S.A, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Mar 29, 2011 as substantially equivalent to K100762 (Fujifilm Medical Systems U.S.A, Inc., 2010) and 1 other predicate after a 111-day review. Its family tree reaches back 7 generations to 1998. 54 later devices descend from it.

Decided: Mar 29, 2011
Review: 111 days
Class: Class II
Product code: MQB
Recalls: None
Predicates: 2

Its longest line of descent runs back 7 generations to K981556 (1998). 14 ancestors in all. 54 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
3 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
2 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
1 generation backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
This deviceK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
Descendant · cites it directly · 52 of its ownK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
Descendant · cites it directly · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
Descendant · 2 generations on · 32 of its ownK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
Descendant · 3 generations on · 26 of its ownK160997 GC85ASamsung Electronics Co., Ltd. · 2016
Descendant · 4 generations on · 23 of its ownK163115 GC70Samsung Electronics Co., Ltd. · 2016

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2011high 9 (2018) · low 1 (2012)2026

Most influential descendants

Showing 5 of 54 · See all

K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · cites it directly52descendants
K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013 · cites it directly50descendants
K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014 · 2 generations on32descendants
K160997GC85ASamsung Electronics Co., Ltd. · 2016 · 3 generations on26descendants
K163115GC70Samsung Electronics Co., Ltd. · 2016 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K981556	Canon X-Ray Digital Camera Cxdi-11	Canon USA, Inc.	1998	—
−6	K992547	Canon X-Ray Digital Camera, Model Cxdi-22	Canon USA, Inc.	1999	—
−5	K023750	Cannon Digital Radiography Model Cxdi-40G	Canon USA, Inc.	2002	—
−4	K031447	Canon, Digital Radiography, Model Cxdi-50G	Canon, Inc.	2003	—
−3	K060433	Digital Radiography Cxdi-50C	Canon, Inc.	2006	—
−2	K091545	Digital Radiography Cxdi-60C	Canon, Inc.	2009	—
−1	K102012	Digital Radiography	Canon Inc. -Medical Equipment Group	2010	1
0 (this device)	K103596	Wireless/Wired FDR D-Evo Flat Panel Detector	Fujifilm Medical Systems U.S.A, Inc.	2011	—
+1	K111548	Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE	Fujifilm Medical System U.S.A., Inc.	2011	—
+1	K132509	FDR D-Evo Flat Panel Detector System	Fujifilm Medical Systems U.S.A, Inc.	2013	—
+2	K141765	FDR D-Evo Flat Panel Detector System	Fujifilm Medical Systems U.S.A, Inc.	2014	—
+3	K160997	GC85A	Samsung Electronics Co., Ltd.	2016	—
+4	K163115	GC70	Samsung Electronics Co., Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	1	0
2008	1	0
2009	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2016	5	0
2017	6	0
2018	9	0
2019	4	0
2020	4	0
2021	3	0
2022	4	0
2023	1	0
2024	6	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K103596, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQB device

#1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K100762	Flat Panel Detector, Model FDR D-Evo Summary page 1 …ess/Wired FDR D-EVO flat panel detector system, is a modified version of our currently-cleared predicate device, (wired) FDR D-EVO flat panel detector system (DR-ID600), K100762. The predicate device includes the flat panel sensor (DR-IDB00SE), which provides only a wired communication mode. The FDR D-EVO…	Fujifilm Medical Systems U.S.A, Inc.	2010	—
*	K102012	Digital Radiography Summary page 2 …ate device, (wired) FDR D-EVO system (K100762). In addition, wireless communication specifications are substantially equivalent to the predicate Canon CXDI-70C Wireless (K102012). CONCLUSION— The Wireless/Wired FDR D-EVO flat panel detector system is substantially equivalent to the cleared predicate devic…	Canon Inc. -Medical Equipment Group	2010	1

Also cleared against K100762: 1 other device →

What descends from it? (54)

See all 54

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111548	Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE	Fujifilm Medical System U.S.A., Inc.	2011	52
K132509	FDR D-Evo Flat Panel Detector System	Fujifilm Medical Systems U.S.A, Inc.	2013	50
K120629	FDR GO Flex	Fujifilm Medical System U.S.A., Inc.	2012	0
K111865	Wired/ Wireless FDR D-Evo with X-Ray Detection Feature	Fujifilm Medical System U.S.A., Inc.	2011	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
3 of the 14 ancestors have a recall of any class.
Of its descendants, K111548 (Fujifilm Medical System U.S.A., Inc., 2011) has gone furthest, with 52 descendants of its own.
1 other device also cites its predicate K100762.

How does its category compare?

All MQB devices

MQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MQB

8in 2025

2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007high 245 (2026) · low 15 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQB

1in 2025

2007high 36 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQB

141in 2025

2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	22	15	25
2008	8	15	36	30
2009	15	57	19	34
2010	11	116	14	39
2011	24	102	10	101
2012	22	80	8	267
2013	21	105	6	159
2014	32	102	0	29
2015	21	81	0	21
2016	22	92	0	26
2017	31	30	1	20
2018	16	30	4	84
2019	22	30	1	45
2020	19	28	4	9
2021	21	48	1	26
2022	31	48	0	13
2023	10	30	0	51
2024	8	187	0	91
2025	8	127	1	141
2026	3	245	1	—

What is it indicated for?

The Wireless/Wired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K103596 · printed Nov 4, 2026

Cite this page

510(k) Report. “K103596: Wireless/Wired FDR D-Evo Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103596

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026