510(k) · Cleared
ClearedX Twin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roesys GmbH · KPR System, X-Ray, Stationary
Cleared on Dec 3, 2014 as substantially equivalent to K070528 (Philips Medical Systems GmbH, Dmc, 2007) after a 384-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Dec 3, 2014
- Review
- 384 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070528 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070528 Philips Essenta DRPhilips Medical Systems GmbH, Dmc · 2007 · Recalled
- This deviceK133496 X Twin SystemRoesys GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070528 | Philips Essenta DR | Philips Medical Systems GmbH, Dmc | 2007 | 4 |
| 0 (this device) | K133496 | X Twin System | Roesys GmbH | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K070528 | Philips Essenta DRSummary page 5…ass II Predicate device: Device Trade Name: Essenta DR Applicant: Philips Medical Systems DMC GmbH 510(k) No.: K070528 Device Description: X Twin The X Twin is a digital multifunctional x-ray system, in which an X Twin stand holds the… | 2007 |
| † | K122589 | DFP4343C7 | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position.
The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133496: X Twin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133496
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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