510(k) · Cleared
ClearedDigital Radiography System, Model QXR-16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vieworks Co., Ltd. · KPR System, X-Ray, Stationary
Cleared on Apr 16, 2008 as substantially equivalent to K073056 (Vieworks Co., Ltd., 2007) after a 48-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 16, 2008
- Review
- 48 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973710 (1997). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973710 Digital Add on Multi SystemSwissray International, Inc. · 1997
- 1 generation backK073056 Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007
- This deviceK080553 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 ownK082261 Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973710 | Digital Add on Multi System | Swissray International, Inc. | 1997 | — |
| −1 | K073056 | Digital Radiography System, Model: QXR-9 | Vieworks Co., Ltd. | 2007 | — |
| 0 (this device) | 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 | 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 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K073056 | Digital Radiography System, Model: QXR-9Summary page 1…, x-ray, stationary 3. Predicate Devices: Manufacturer :Vieworks Co., Ltd. Device :QXR-9 510(k) Number :K073056(Decision Date - 11. 13. 2007) 4. Classifications Names & Citations: 21CFR 892.1680, KPR - System, x-ray, stationary, Class… | 2007 |
| * | — | AddOn Multi System Named without a submission number |
What descends from it? (2)
2 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 11 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K101779 (Jpi Healthcare Co, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073056.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
QXR-16 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 procedures. Not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080553: Digital Radiography System, Model QXR-16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080553
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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