510(k) · Cleared
ClearedKrystal-X Wifi
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 5, 2007 as substantially equivalent to K050693 (Air Techniques, Inc., 2005) and 2 other predicates after a 43-day review. Its family tree reaches back 2 generations to 1994. 44 later devices descend from it.
- Decided
- Apr 5, 2007
- Review
- 43 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K933455 (1994). 6 ancestors in all. 44 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 1 generation backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- This deviceK070505 Krystal-X WifiOwandy · 2007
- Descendant · cites it directly · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 2 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 4 generations on · 10 of its ownK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · cites it directly43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 2 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on23descendants
- K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on18descendants
- K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −1 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| 0 (this device) | K070505 | Krystal-X Wifi | Owandy | 2007 | — |
| +1 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +2 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
| +3 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +4 | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K061114 | FDA’s K061114 is WDS, Size 2 and Size 2 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K050693 | AccentSummary page 1…nventional X-ray tube and image capture software, currently available commercially. * Summary of Substantial Eguivalence Compgarison KO0i1114 - WDS X-RAY, CEFLA K050693 -ACCENT, AIR TECHNIQUES, INC. K022953 - CDR Wireless, SCHICK TECHNOLOGI ES K0531 72 - KRYSTAL-X, The proposed and predicated dev… | 2005 |
| * | K022953 | Modification to Computed Oral Radiology SystemSummary page 1…e software, currently available commercially. * Summary of Substantial Eguivalence Compgarison KO0i1114 - WDS X-RAY, CEFLA K050693 -ACCENT, AIR TECHNIQUES, INC. K022953 - CDR Wireless, SCHICK TECHNOLOGI ES K0531 72 - KRYSTAL-X, The proposed and predicated devices use similar components and are si… | 2002 |
| * | K053172 | Universal-X (Usa) or /Krystal-X (Europe)Summary page 1…* Summary of Substantial Eguivalence Compgarison KO0i1114 - WDS X-RAY, CEFLA K050693 -ACCENT, AIR TECHNIQUES, INC. K022953 - CDR Wireless, SCHICK TECHNOLOGI ES K0531 72 - KRYSTAL-X, The proposed and predicated devices use similar components and are similar in design, technical characteristics and… | 2006 |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081722 | YSIO | 2008 | 43 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K081722 (Siemens Medical Solutions USA, Inc., 2008) has gone furthest, with 43 descendants of its own.
- 4 other devices also cite its predicate K050693.
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. 2007, 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 KRYSTAL-X WiFI digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFI), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure…
Read the full statement (205 words)
The KRYSTAL-X WiFI digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube (which is a third party device, not part of Krystal-X WiFI), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are: high definition, ensuring high-value diagnostics, and reduction of X-ray dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070505: Krystal-X Wifi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070505
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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