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 (Shanghai), Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 8, 2016 as substantially equivalent to K152279 (Viztek, LLC, 2015) after a 168-day review. Its family tree reaches back 10 generations to 1998. 24 later devices descend from it.
- Decided
- Dec 8, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K981556 (1998). 21 ancestors in all. 24 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK112661 Vizion DRViztek, LLC · 2011
- 2 generations backK123644 Vizion + DRViztek, LLC · 2013
- 1 generation backK152279 ViZion DR + WirelessViztek, LLC · 2015
- This deviceK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- Descendant · cites it directly · 18 of its ownK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
- Descendant · 2 generations on · 9 of its ownK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
- Descendant · 3 generations on · 7 of its ownK201043 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020
- Descendant · 4 generations on · 4 of its ownK210314 Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK201004 Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI…Iray Technology Taicang, Ltd. · 2020
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 backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 5 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 4 generations backK102123 Vizion DRViztek, Inc. · 2011
- 3 generations backK112661 Vizion DRViztek, LLC · 2011
- 2 generations backK123644 Vizion + DRViztek, LLC · 2013
- 1 generation backK152279 ViZion DR + WirelessViztek, LLC · 2015
- This deviceK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018 · cites it directly18descendants
- K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019 · 2 generations on9descendants
- K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)Iray Technology Taicang, Ltd. · 2020 · 3 generations on7descendants
- K210314Mars1717X Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2021 · 4 generations on4descendants
- K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat…Iray Technology Taicang, Ltd. · 2020 · 2 generations on4descendants
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 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −5 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −4 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −3 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −2 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −1 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| 0 (this device) | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| +1 | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
| +2 | K183713 | Wireless Digital Flat Detector | Iray Technology Taicang, Ltd. | 2019 | — |
| +3 | K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang, Ltd. | 2020 | — |
| +4 | K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2021 | — |
| +2 | K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless… | Iray Technology Taicang, Ltd. | 2020 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 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 |
|---|---|---|---|
| * | K152279 | ViZion DR + WirelessSummary page 6…less Product Code: MQB SECTION 7-2 of 8 iRay Technology (Shanghai) Ltd [510(k)] Application Classification Name: Stationary X-Ray System FDA 510 (k) #: K152279 5. Description of the Device [21 CFR 807.92(a)(4)] Mars1417V-PSI Wireless Digital Flat Panel Detector is a kind of wireless dig… | 2015 |
| † | K063337 | Opal-Rad | 2006 |
What descends from it? (24)
See all 244 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 18 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K182551 (Iray Technology Taicang, Ltd., 2018) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K152279.
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. 2016, 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?
Mars1417V-PSI 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161730: 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/K161730
Report an extraction error
Are you the manufacturer?
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