510(k) · Cleared
ClearedDigital Radiography System, Model: QXR-9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vieworks Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 13, 2007 as substantially equivalent to K061595 (Imaging Dynamics Company, Ltd., 2006) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Nov 13, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973710 (1997). 2 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK973710 Digital Add on Multi SystemSwissray International, Inc. · 1997
- This deviceK073056 Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007
- Descendant · cites it directly · 2 of its ownK080553 Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK101779 Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK100703 Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK082261 Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K080553Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008 · cites it directly2descendants
- K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011 · cites it directly0descendants
- K100703Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010 · cites it directly0descendants
- K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973710 | Digital Add on Multi System | Swissray International, Inc. | 1997 | — |
| 0 (this device) | K073056 | Digital Radiography System, Model: QXR-9 | Vieworks Co., Ltd. | 2007 | — |
| +1 | K080553 | Digital Radiography System, Model QXR-16 | Vieworks Co., Ltd. | 2008 | — |
| +1 | K101779 | Clearvision DR 2000 Digital Radiography X-Ray System | Jpi Healthcare Co, Ltd. | 2011 | — |
| +1 | K100703 | Stationary X-Ray System (Detector) Model: Altas | Comed Co., Ltd. | 2010 | — |
| +1 | K082261 | Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems | Dxrad Solutions, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K061595 | XaminerSummary page 1…phy System Classification Name : Solid State X-ray Imaging Device 3. Predicate Devices : Manufacturer : IMAGING DYNAMICS COMPANY LTD. Device : XAMINER 510(k) Number 1 K061595(Decision Date - 8. 17. 2006) Manufacturer : Swissray International, Inc. Device : AddOn Multi System 510(k) Number : K973710(De… | 2006 |
| * | K973710 | Digital Add on Multi SystemSummary page 1…ANY LTD. Device : XAMINER 510(k) Number 1 K061595(Decision Date - 8. 17. 2006) Manufacturer : Swissray International, Inc. Device : AddOn Multi System 510(k) Number : K973710(Decision Date — 12. 18. 1997) 4. Classifications Names & Citations : 21CFR 892.1650, MQB - Solid State X-ray Imaging Device, Cla… | 1997 |
What descends from it? (4)
4 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?
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. 2007, 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?
QXR-9 Digital Radiography system is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic pracedures. Not to be used for mammography.
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/K073056 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073056: Digital Radiography System, Model: QXR-9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073056
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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