510(k) · Cleared
ClearedTrophy Radiologie RVG 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 Jun 30, 1995 after a 147-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 30, 1995
- Review
- 147 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK950533 Trophy Radiologie RVG RadiovisiographyTrophy Radiologie · 1995
- Descendant · cites it directly · 2 of its ownK092537 Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
- Descendant · cites it directly · 0 of its ownK041831 Progeny Mpse Intraoral Dental X-Ray SensorProgeny, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009 · cites it directly2descendants
- K110886Clio/CliosoftSota Precision Optics, Inc. · 2011 · 2 generations on1descendant
- K241495Jazz ClassicJazz Imaging · 2024 · 3 generations on0descendants
- K041831Progeny Mpse Intraoral Dental X-Ray SensorProgeny, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950533 | Trophy Radiologie RVG Radiovisiography | Trophy Radiologie | 1995 | — |
| +1 | K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | 2009 | — |
| +2 | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| +3 | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
| +1 | K041831 | Progeny Mpse Intraoral Dental X-Ray Sensor | Progeny, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2024 | 1 | 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? (4)
2 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, K092537 (Toshiba America Electronic Components, Inc., 2009) has gone furthest, with 2 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/K950533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950533: Trophy Radiologie RVG Radiovisiography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950533
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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