510(k) · Cleared
ClearedDdrversa Motion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swissray Medical AG · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 7, 2012 as substantially equivalent to K110828 (Swissray Medical AG, 2011) and 1 other predicate after a 71-day review. Its family tree reaches back 5 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 7, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001201 (2000). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- 4 generations backK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001 · Recalled
- 3 generations backK072659 Rad Vision, Models E and EUAlmana Medical Imaging · 2007
- 2 generations backK082064 Radvision ET Diagnostic X-Ray SystemAlmana Medical Imaging · 2008
- 1 generation backK083109 Suinsa Diagnostic X-Ray SystemSuinsa · 2008
- This deviceK123005 Ddrversa MotionSwissray Medical AG · 2012
- Descendant · cites it directly · 3 of its ownK141381 DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK163410 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK201725 DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK201640 DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K141381DuradiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2014 · cites it directly3descendants
- K163410DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · 2017 · 2 generations on1descendant
- K201725DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Lit. · 2020 · 3 generations on0descendants
- K201640DuraDiagnostPhilips Healthcare (Suzhou) Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −4 | K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc. | 2001 | 2 |
| −3 | K072659 | Rad Vision, Models E and EU | Almana Medical Imaging | 2007 | — |
| −2 | K082064 | Radvision ET Diagnostic X-Ray System | Almana Medical Imaging | 2008 | — |
| −1 | K083109 | Suinsa Diagnostic X-Ray System | Suinsa | 2008 | — |
| 0 (this device) | K123005 | Ddrversa Motion | Swissray Medical AG | 2012 | — |
| +1 | K141381 | Duradiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2014 | 7 |
| +2 | K163410 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Ltd. | 2017 | 4 |
| +3 | K201725 | DigitalDiagnost C50 | Philips Healthcare (Suzhou) Co., Lit. | 2020 | 3 |
| +2 | K201640 | DuraDiagnost | Philips Healthcare (Suzhou) Co., Ltd. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K110828 | DdrelementSummary page 1….1680 Device class: 11,Panel: Radiology, Product code: MOB and KPR 3. Predicate Device: This is a MODIFICATION to ddRElement M under document number K110828 and Suinsa (Now owned by Sedecal) (K(083109). 4. A description of the device: ddRVersa TM Motion uses the sam… | 2011 |
| * | K083109 | Suinsa Diagnostic X-Ray SystemSummary page 1…ddE rmeta Motion ChrceitcSedecal) dd~e et"(K123005) (New (K083109) (K110828) modified device)_ Overall Configuration -… | 2008 |
| † | K090742 | Digital Flat Panel X-Ray Detector, Model LTX240AA01-a | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141381 | Duradiagnost | 2014 | 3 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K141381 (Philips Healthcare (Suzhou) Co., Ltd., 2014) has gone furthest, with 3 descendants of its own.
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. 2012, 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?
The ddRVersaTrM Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123005: Ddrversa Motion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123005
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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