510(k) · Cleared
ClearedFDR D-Evo II Flat Panel Detector System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Oct 21, 2014 as substantially equivalent to K132509 (Fujifilm Medical Systems U.S.A, Inc., 2013) after a 90-day review. Its family tree reaches back 10 generations to 1998. 16 later devices descend from it.
- Decided
- Oct 21, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K981556 (1998). 17 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 2 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- This deviceK142003 FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2014
- Descendant · cites it directly · 9 of its ownK191939 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2019
- Descendant · 2 generations on · 7 of its ownK201528 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2020
- Descendant · 3 generations on · 5 of its ownK220510 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2022
- Descendant · 3 generations on · 5 of its ownK210988 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2021
- Descendant · 3 generations on · 1 of its ownK243171 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2024
Show all 10 generations
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 8 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 7 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 6 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 5 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 4 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 3 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 2 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- This deviceK142003 FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K191939Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2019 · cites it directly9descendants
- K201528Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2020 · 2 generations on7descendants
- K220510Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2022 · 3 generations on5descendants
- K210988Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2021 · 3 generations on5descendants
- K243171Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −9 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −8 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −7 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −6 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −5 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −4 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −3 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −2 | 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 | — |
| 0 (this device) | K142003 | FDR D-Evo II Flat Panel Detector System | Fujifilm Medical System U.S.A., Inc. | 2014 | — |
| +1 | K191939 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2019 | — |
| +2 | K201528 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2020 | — |
| +3 | K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2022 | — |
| +3 | K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2021 | — |
| +3 | K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K132509 | FDR D-Evo Flat Panel Detector SystemSummary page 7…ommon Name: Flat Panel Digital Detector System Identification of the Legally Marketed Device: FDR D-EVO Flat Panel Detector System (DR-ID600), K132509 cleared 11/25/2013 I. DEVICE DESCRIPTION Fujifilm’s FDR D-EVO II Flat Panel Detector System (DR-ID1200) is a portable… | 2013 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K191939 (Innocare Optoelectronics Corp., 2019) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K132509.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 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 II 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 including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO II 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/K142003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142003: FDR D-Evo II Flat Panel Detector System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142003
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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