510(k) · Cleared
ClearedRSV (Radiology System Visiodent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visiodent SA · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 31, 2003 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 66 later devices descend from it.
- Decided
- Jul 31, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
66 later devices descend from it, 3 citing it directly.
- This deviceK031448 RSV (Radiology System VisiodentVisiodent SA · 2003
- 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 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · 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) | K031448 | RSV (Radiology System Visiodent | Visiodent SA | 2003 | — |
| +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 |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (66)
See all 663 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 EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The RSV (Radiology System Visiodent) device is used to
provide instant images of x-rayed human oral tissue and teeth
without the use of conventional x-ray films.
This is achieved by using the conventional x-ray tube, but by
placing an electronic sensor, instead of film, inside the patient’s
mouth. The sensor, upon radiation exposure, automatically
captures the images into a computer for viewing, storage,
printing and manipulation of the x-rays.
RSV is therefore similar to Trophy’s RVG and Video Dental
Concept’s QuickRay and several other legal systems, in its
intended use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031448: RSV (Radiology System Visiodent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031448
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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