510(k) · Cleared
ClearedYushan X-Ray Flat Panel Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innocare Optoelectronics Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 19, 2024 as substantially equivalent to K201528 (Innocare Optoelectronics Corp., 2020) and 2 other predicates after an 80-day review. Its family tree reaches back 14 generations to 1998. 1 later device descends from it.
- Decided
- Dec 19, 2024
- Review
- 80 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 deviceK243171 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2024
- Descendant · cites it directly · 0 of its ownK250211 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 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 deviceK243171 Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 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) | K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024 | — |
| +1 | K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 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…CE Substantial equivalence to the following predicate device is as follows: a. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K201528 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product cod… | 2020 |
| * | K210988 | Yushan X-Ray Flat Panel Detector with DROCSummary page 6…5-1 Device class: Class II b. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K210988 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product cod… | 2021 |
| * | K220510 | Yushan X-Ray Flat Panel Detector with DROCSummary page 6…eview panel: Radiology Product code: MQB Regulation number: 21 CFR 892.1680 c. Trade/Device Name: Yushan X-Ray Flat Panel Detector with DROC FDA 510(k) clearance number: K220510 Manufacturer: InnoCare Optoelectronics Corp. Regulation description: Stationary x-ray system. Review panel: Radiology Product cod… | 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 |
|---|---|---|---|
| K250211 | Yushan X-Ray Flat Panel Detector | 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 26 years and passes through 6 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, K250211 (Innocare Optoelectronics Corp., 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. 2024, 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 (V14C, V14G, F14C, F14G, V17C, V17G)/Wired (V14C, V14G, F14C, F14G, V17C, V17G, V17Ge, V17Ce) Yushan X-Ray Flat Panel Detector 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 Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician.
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/K243171 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243171: Yushan X-Ray Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243171
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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