510(k) · Cleared
ClearedOpteo, Videograph HD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owandy · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 28, 2014 as substantially equivalent to K093105 (Owandy, 2010) after a 186-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it.
- Decided
- Apr 28, 2014
- Review
- 186 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950532 (1995). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK950532 Trophy Radiologie RVG Portable RadiovisiographyTrophy Radiologie · 1995
- 2 generations backK053172 Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006
- 1 generation backK093105 VisteoOwandy · 2010
- This deviceK133271 Opteo, Videograph HDOwandy · 2014
- Descendant · cites it directly · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK163282 Apex Dental SensorsMasterlink, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK162619 I View and Imagen SensorTrident S.R.L · 2016
- Descendant · 2 generations on · 0 of its ownK230916 WeSensorPicopack, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK202369 RXS 1000Rolence Enterprise, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · cites it directly10descendants
- K163282Apex Dental SensorsMasterlink, LLC · 2017 · 2 generations on2descendants
- K162619I View and Imagen SensorTrident S.R.L · 2016 · 2 generations on1descendant
- K230916WeSensorPicopack, Inc. · 2023 · 2 generations on0descendants
- K202369RXS 1000Rolence Enterprise, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950532 | Trophy Radiologie RVG Portable Radiovisiography | Trophy Radiologie | 1995 | — |
| −2 | K053172 | Universal-X (Usa) or /Krystal-X (Europe) | Owandy Sas | 2006 | — |
| −1 | K093105 | Visteo | Owandy | 2010 | — |
| 0 (this device) | K133271 | Opteo, Videograph HD | Owandy | 2014 | — |
| +1 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| +2 | K163282 | Apex Dental Sensors | Masterlink, LLC | 2017 | — |
| +2 | K162619 | I View and Imagen Sensor | Trident S.R.L | 2016 | — |
| +2 | K230916 | WeSensor | Picopack, Inc. | 2023 | — |
| +3 | K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021 | — |
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 |
|---|---|---|
| 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K093105 | VisteoSummary page 1…ationName: Extracral Source X-Ray System (Component); 21 CFR 872.1800; Product Code MUff PredicateDevice: Visteo (Owandy) K093105 Device Description: lntraoral detector for capturing x-ray images from an extraoral source generator. Capture… | 2010 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151926 | QuickRay HD Intraoral Sensor | 2015 | 10 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K151926 (Denterprise International, Inc., 2015) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Opteo 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 Opteo is covered with a single use disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray. The dental x-ray tube (which is not part of Opteo) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133271: Opteo, Videograph HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133271
Report an extraction error
Are you the manufacturer?
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