510(k) · Cleared
Recalled · Class II · 2018Ddrcombi Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swissray International, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 26, 2005 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- May 26, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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 |
|---|---|---|---|
| * | — | AddOn Multi System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2018 | Class II | Z-0697-2019 | Component design/selection | A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope of the lifting column, which is designed to take the load, can break without… |
No ancestor or descendant has a Class I recall.
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.
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?
The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class Il (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms. The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position. With the fix height adjustable patient table and the new flexible detector…
Read the full statement (205 words)
The Swissray Medical AG Direct Digital X-ray Radiography diagnostic system class Il (stationary) ddRCombi Trauma is a further development of the AddOn Multi System. This system can be used in a standard X-ray room and suitable for emergency / Trauma X-ray rooms.
The ddRCombi Trauma is intend for applying general radiography on a patient in a supine, seated or standing position.
With the fix height adjustable patient table and the new flexible detector positioning, the patient must be no more repositioned for the most X-ray applications.
The ddRCombi Trauma allows the operator a full control of the Patient data, positioning, X-ray parameter (automatic by organ selection or manual setlings), exposure control and image quality.
The operator can use the following image control functions without losing the original exposure:
- Brightness, contrast, shape, rotate, zoom, inverse, cut off etc.
- Storage function (PACS, HL 7) included all X-ray parameter and patient information
The ddRCambi Trauma allows the operator to print images (DICOM format) in background on a laser printer (the most printer suppliers are avaitable) or CO-ROM.
The major system components are:
fix height adjustable patient table, X-ray generator, X-ray tube, Collimator, stand, ceiling suspension, digital AddOn bucky (4 CCD cameras), Image processing software and monitors.
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/K050718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050718: Ddrcombi Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026