510(k) · Cleared
ClearedWireless Digital Flat Panel 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 Oct 17, 2018 as substantially equivalent to K161730 (Iray Technology (Shanghai), Ltd., 2016) after a 30-day review. Its family tree reaches back 11 generations to 1998. 18 later devices descend from it.
- Decided
- Oct 17, 2018
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K981556 (1998). 22 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
- Descendant · cites it directly · 9 of its ownK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
- Descendant · 2 generations on · 7 of its ownK201043 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK201004 Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI…Iray Technology Taicang, Ltd. · 2020
- Descendant · 4 generations on · 3 of its ownK213529 Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 6 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 5 generations backK102123 Vizion DRViztek, Inc. · 2011
- 4 generations backK112661 Vizion DRViztek, LLC · 2011
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019 · cites it directly9descendants
- K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020 · 2 generations on7descendants
- K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021 · 3 generations on4descendants
- K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd. · 2020 · cites it directly4descendants
- K213529Focus HD 43 DetectorIray Technology Taicang, Ltd. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −6 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −5 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −4 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −2 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| −1 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| 0 (this device) | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
| +1 | 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 | — |
| +3 | K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2021 | — |
| +1 | K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless… | Iray Technology Taicang, Ltd. | 2020 | — |
| +4 | K213529 | Focus HD 43 Detector | Iray Technology Taicang, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 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 |
|---|---|---|---|
| * | K161730 | Wireless Digital Flat Panel DetectorSummary page 5…Mars1417V-PSI Product Code: MQB Classification Name: Stationary X-Ray System FDA 510 (k) #: K161730 5. Description of the Device [21 CFR 807.92(a)(4)] Mars1417XF-CSI Wireless Digital Flat Panel Detector is a kind of wireless… | 2016 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183713 | Wireless Digital Flat Detector | 2019 | 9 |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat… | 2020 | 4 |
| K192512 | Focus 35C Detector, Trimax 35C Detector | 2019 | 0 |
| K190300 | BIOK7600W Wireless Flat Panel Detector | 2019 | 0 |
| K190311 | BIOK7600 Flat Panel Detector | 2019 | 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 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K183713 (Iray Technology Taicang, Ltd., 2019) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K161730.
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. 2018, 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?
Mars1417XF-&SI Wireless Digital Flat Panel Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182551: Wireless Digital Flat Panel Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182551
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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