510(k) · Cleared
ClearedUniversal-X (Usa) or /Krystal-X (Europe)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owandy Sas · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jun 9, 2006 as substantially equivalent to K950532 (Trophy Radiologie, 1995) and 1 other predicate after a 207-day review. Its family tree reaches back 1 generation to 1995. 58 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 207 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950532 (1995). 2 ancestors in all. 58 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950532 Trophy Radiologie RVG Portable RadiovisiographyTrophy Radiologie · 1995
- This deviceK053172 Universal-X (Usa) or /Krystal-X (Europe)Owandy Sas · 2006
- Descendant · cites it directly · 44 of its ownK070505 Krystal-X WifiOwandy · 2007
- Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 3 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K070505Krystal-X WifiOwandy · 2007 · cites it directly44descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 3 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on23descendants
- K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950532 | Trophy Radiologie RVG Portable Radiovisiography | Trophy Radiologie | 1995 | — |
| 0 (this device) | K053172 | Universal-X (Usa) or /Krystal-X (Europe) | Owandy Sas | 2006 | — |
| +1 | K070505 | Krystal-X Wifi | Owandy | 2007 | — |
| +2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +3 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +3 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
| +4 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
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 |
|---|---|---|
| 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), 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? (2)
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 |
|---|---|---|---|
| * | K950532 | Trophy Radiologie RVG Portable RadiovisiographySummary page 2…s substantially equivalent to several other digital dental imaging systems currently legally marketed in United States. The equivalent system examined ar the RVG TROPHY (K950532) and the RSV VISIODENT (K031448). All these products are intended to be used with a Dental X-ray source, a Dental inage Managemen… | 1995 |
| * | K031448 | RSV (Radiology System VisiodentSummary page 2…veral other digital dental imaging systems currently legally marketed in United States. The equivalent system examined ar the RVG TROPHY (K950532) and the RSV VISIODENT (K031448). All these products are intended to be used with a Dental X-ray source, a Dental inage Management Application Software and stand… | 2003 |
What descends from it? (58)
See all 582 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?
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.
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 UNLVERSAL-X 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 Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray. The dental X-ray tube (which is not part of Universal-X) is pointed at the…
Read the full statement (148 words)
The UNLVERSAL-X 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 Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray. The dental X-ray tube (which is not part of Universal-X) 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. Similar devices have been in use in the USA since 1989, and are now well accepted by dentists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053172 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053172: Universal-X (Usa) or /Krystal-X (Europe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053172
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