510(k) · Cleared
ClearedVisteo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owandy · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Oct 18, 2010 as substantially equivalent to K053172 (Owandy Sas, 2006) after a 382-day review. Its family tree reaches back 2 generations to 1995. 12 later devices descend from it.
- Decided
- Oct 18, 2010
- Review
- 382 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950532 (1995). 3 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950532 Trophy Radiologie RVG Portable RadiovisiographyTrophy Radiologie · 1995
- 1 generation backK053172 Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006
- This deviceK093105 VisteoOwandy · 2010
- Descendant · cites it directly · 11 of its ownK133271 Opteo, Videograph HDOwandy · 2014
- Descendant · 2 generations on · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK163282 Apex Dental SensorsMasterlink, LLC · 2017
- Descendant · 3 generations on · 1 of its ownK162619 I View and Imagen SensorTrident S.R.L · 2016
- Descendant · 3 generations on · 0 of its ownK230916 WeSensorPicopack, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K133271Opteo, Videograph HDOwandy · 2014 · cites it directly11descendants
- K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · 2 generations on10descendants
- K163282Apex Dental SensorsMasterlink, LLC · 2017 · 3 generations on2descendants
- K162619I View and Imagen SensorTrident S.R.L · 2016 · 3 generations on1descendant
- K230916WeSensorPicopack, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950532 | Trophy Radiologie RVG Portable Radiovisiography | Trophy Radiologie | 1995 | — |
| −1 | K053172 | Universal-X (Usa) or /Krystal-X (Europe) | Owandy Sas | 2006 | — |
| 0 (this device) | K093105 | Visteo | Owandy | 2010 | — |
| +1 | K133271 | Opteo, Videograph HD | Owandy | 2014 | — |
| +2 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| +3 | K163282 | Apex Dental Sensors | Masterlink, LLC | 2017 | — |
| +3 | K162619 | I View and Imagen Sensor | Trident S.R.L | 2016 | — |
| +3 | K230916 | WeSensor | Picopack, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K053172 | Universal-X (Usa) or /Krystal-X (Europe)Summary page 1…name Proprietary name: VISTEO Classification name : Extra oral source X-Ray System accessory Common name : Digital dental imaging device Predicate devices UNIVERSAL-X : K053172 Manufacturer/Applicant = OWANDY Device description The VISTEO system consists of the following components: the… | 2006 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133271 | Opteo, Videograph HD | 2014 | 11 |
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 15 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133271 (Owandy, 2014) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K053172.
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. 2010, this device’s year, is highlighted.
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 VISTEO digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The VISTEC is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentists wishes to X-Ray. The dental X-ray tube (which is not part of VISTEO) is pointed at the sensor and…
Read the full statement (130 words)
The VISTEO digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film.
It is used with a conventional X-ray tube and a Computer for dental radiographic imaging.
The VISTEC is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentists wishes to X-Ray.
The dental X-ray tube (which is not part of VISTEO) is pointed at the sensor and activated.
The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.
In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093105: Visteo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093105
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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