510(k) · Cleared
ClearedFocus HD 43 Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iray Technology Taicang, Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 29, 2022 as substantially equivalent to K210314 (Iray Technology Taicang, Ltd., 2021) after a 145-day review. Its family tree reaches back 15 generations to 1998. 3 later devices descend from it.
- Decided
- Mar 29, 2022
- Review
- 145 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K981556 (1998). 26 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 11 generations between
- 3 generations backK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
- 2 generations backK201043 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020
- 1 generation backK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- This deviceK213529 Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK243556 Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 2025
- Descendant · 2 generations on · 0 of its ownK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
- Descendant · 2 generations on · 0 of its ownK252911 Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited · 2025
Show all 15 generations
- Root · 15 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 14 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 13 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 12 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 11 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 10 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 9 generations backK102123 Vizion DRViztek, Inc. · 2011
- 8 generations backK112661 Vizion DRViztek, LLC · 2011
- 7 generations backK123644 Vizion + DRViztek, LLC · 2013
- 6 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 5 generations backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- 4 generations backK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
- 3 generations backK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
- 2 generations backK201043 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020
- 1 generation backK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- This deviceK213529 Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K243556Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited · 2025 · cites it directly2descendants
- K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health · 2026 · 2 generations on0descendants
- K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −14 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −13 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −12 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −11 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −10 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −9 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −8 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −7 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −6 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| −5 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| −4 | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
| −3 | K183713 | Wireless Digital Flat Detector | Iray Technology Taicang, Ltd. | 2019 | — |
| −2 | K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang, Ltd. | 2020 | — |
| −1 | K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2021 | — |
| 0 (this device) | K213529 | Focus HD 43 Detector | Iray Technology Taicang, Ltd. | 2022 | — |
| +1 | K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025 | — |
| +2 | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35… | Carestream Health | 2026 | — |
| +2 | K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K210314 | Mars1717X Wireless Digital Flat Panel DetectorSummary page 5…Stationary X-Ray System Regulation Number: 21 CFR 892.1680 Device Class: Class II FDA 510 (k) #: K210314 5. Description of the Device [21 CFR 807.92(a)(4)] Focus HD 43 Detector is a kind of wireless digital flat panel detector. It… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | 2025 | 2 |
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.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K243556 (Iray Imaging Technology (Haining) Limited, 2025) has gone furthest, with 2 descendants of its own.
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?
Focus HD 43 Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213529: Focus HD 43 Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213529
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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