510(k) · Cleared
ClearedTrophy Radiologie RVG Portable Radiovisiography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trophy Radiologie · EAP Unit, X-Ray, Intraoral
Cleared on Apr 19, 1995 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 60 later devices descend from it.
- Decided
- Apr 19, 1995
- Review
- 71 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly.
- This deviceK950532 Trophy Radiologie RVG Portable RadiovisiographyTrophy Radiologie · 1995
- Descendant · cites it directly · 58 of its ownK053172 Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006
- Descendant · 2 generations on · 44 of its ownK070505 Krystal-X WifiOwandy · 2007
- Descendant · 3 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 4 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K053172Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006 · cites it directly58descendants
- K070505Krystal-X WifiOwandy · 2007 · 2 generations on44descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 3 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 4 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950532 | Trophy Radiologie RVG Portable Radiovisiography | Trophy Radiologie | 1995 | — |
| +1 | K053172 | Universal-X (Usa) or /Krystal-X (Europe) | Owandy Sas | 2006 | — |
| +2 | K070505 | Krystal-X Wifi | Owandy | 2007 | — |
| +3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +4 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +4 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (60)
See all 602 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?
- Of its descendants, K053172 (Owandy Sas, 2006) has gone furthest, with 58 descendants of its own.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950532: Trophy Radiologie RVG Portable Radiovisiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950532
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026