510(k) · Cleared
ClearedWireless/Wired X-Ray Flat Panel Detectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Medical Systems Limited · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 27, 2022 as substantially equivalent to K201528 (Innocare Optoelectronics Corp., 2020) and 2 other predicates after a 59-day review. Its family tree reaches back 14 generations to 1998. 1 later device descends from it.
- Decided
- Nov 27, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K981556 (1998). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations between
- 3 generations backK191939 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2019
- 2 generations backK201528 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2020
- 1 generation backK210988 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2021
- This deviceK223009 Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited · 2022
- Descendant · cites it directly · 0 of its ownK243734 Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited · 2025
Show all 14 generations
- Root · 14 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 13 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 12 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 11 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 10 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 9 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 8 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 7 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 6 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 5 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 4 generations backK142003 FDR D-Evo II Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2014
- 3 generations backK191939 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2019
- 2 generations backK201528 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2020
- 1 generation backK210988 Yushan X-Ray Flat Panel Detector with DROCInnocare Optoelectronics Corp. · 2021
- This deviceK223009 Wireless/Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited · 2022
Most influential descendants
Showing 1 of 1 · See all- K243734Wireless/ Wired X-Ray Flat Panel DetectorsAllengers Medical Systems Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −13 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −12 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −11 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −10 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −9 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −8 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −7 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −6 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −5 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| −4 | K142003 | FDR D-Evo II Flat Panel Detector System | Fujifilm Medical System U.S.A., Inc. | 2014 | — |
| −3 | 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 | — |
| −1 | K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2021 | — |
| 0 (this device) | K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2022 | — |
| +1 | K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025 | — |
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 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K201528 | Yushan X-Ray Flat Panel Detector with DROCSummary page 5…ubstantial equivalence to the following predicate device is as follows: Device (trade) name: Yushan X-Ray Flat Panel Detector with DROC 510(K) Number : K201528 Manufacturer : InnoCare Optoelectronics Corp. Decision Date : October 11, 2020 Regulation de… | 2020 |
| * | K210988 | Yushan X-Ray Flat Panel Detector with DROCSummary page 5…Device Class : Class II Product Code: MQB Device (trade) name: Yushan X-Ray Flat Panel Detector with DROC 510(K) Number : K210988 Manufacturer : InnoCare Optoelectronics Corp. Decision Date : April 21, 2021 Regulation desc… | 2021 |
| * | K220510 | Yushan X-Ray Flat Panel Detector with DROCSummary page 5…Device Class : Class II Product Code: MQB Device (trade) name: Yushan X-Ray Flat Panel Detector with DROC 510(K) Number : K220510 Manufacturer : InnoCare Optoelectronics Corp. Decision Date : April 14, 2022 Regulation desc… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | 2025 | 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 24 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K243734 (Allengers Medical Systems Limited, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K201528.
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. 2022, 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?
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223009: Wireless/Wired X-Ray Flat Panel Detectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223009
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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