510(k) · Cleared
ClearedDigital Add on Multi System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swissray International, Inc. · KPR System, X-Ray, Stationary
Cleared on Dec 18, 1997 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 18, 1997
- Review
- 80 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK973710 Digital Add on Multi SystemSwissray International, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK073056 Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK080553 Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK101779 Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK100703 Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK082261 Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K073056Digital Radiography System, Model: QXR-9Vieworks Co., Ltd. · 2007 · cites it directly4descendants
- K080553Digital Radiography System, Model QXR-16Vieworks Co., Ltd. · 2008 · 2 generations on2descendants
- K101779Clearvision DR 2000 Digital Radiography X-Ray SystemJpi Healthcare Co, Ltd. · 2011 · 2 generations on0descendants
- K100703Stationary X-Ray System (Detector) Model: AltasComed Co., Ltd. · 2010 · 2 generations on0descendants
- K082261Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic SystemsDxrad Solutions, Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973710 | Digital Add on Multi System | Swissray International, Inc. | 1997 | — |
| +1 | K073056 | Digital Radiography System, Model: QXR-9 | Vieworks Co., Ltd. | 2007 | — |
| +2 | K080553 | Digital Radiography System, Model QXR-16 | Vieworks Co., Ltd. | 2008 | — |
| +2 | K101779 | Clearvision DR 2000 Digital Radiography X-Ray System | Jpi Healthcare Co, Ltd. | 2011 | — |
| +2 | K100703 | Stationary X-Ray System (Detector) Model: Altas | Comed Co., Ltd. | 2010 | — |
| +2 | K082261 | Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems | Dxrad Solutions, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073056 | Digital Radiography System, Model: QXR-9 | 2007 | 4 |
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?
- Of its descendants, K073056 (Vieworks Co., Ltd., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Swissray Telleray AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in muitipurpose or dedicated applications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position. The AddOn multi system allows the operator to…
Read the full statement (131 words)
The Swissray Telleray AG Digital Add-on multi system is a high resolution, digital X-Ray system designed for Digital Photofluorography. It is intended to replace conventional film techniques in muitipurpose or dedicated applications where general Radiography procedures are performed. The AddOn multi System is intended for applying general radiography on a patient in a supine, seated, or standing position.
The AddOn multi system allows the operator to view and enhance the images. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The Add-on multi system enables the operator to hardcopy images with a laser printer. The major system components include: an optional floating table, x-ray generator, x-ray tube, digital AddOn Bucky: CCD camera, monitors and an image processor.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973710: Digital Add on Multi System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973710
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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