510(k) · Cleared
ClearedQuickray DSX 730
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Julie Alliance · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 1, 1999 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 1, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK990002 Quickray DSX 730Julie Alliance · 1999
- Descendant · cites it directly · 5 of its ownK061114 WDS, Size 2 and Size 2Cefla S.C.R.L. · 2006
- Descendant · cites it directly · 3 of its ownK080738 Dentron SensorDentron Systems, LLC · 2008
- Descendant · 2 generations on · 2 of its ownK092537 Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061114WDS, Size 2 and Size 2Cefla S.C.R.L. · 2006 · cites it directly5descendants
- K080738Dentron SensorDentron Systems, LLC · 2008 · cites it directly3descendants
- K092537Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009 · 2 generations on2descendants
- K110886Clio/CliosoftSota Precision Optics, Inc. · 2011 · 3 generations on1descendant
- K241495Jazz ClassicJazz Imaging · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990002 | Quickray DSX 730 | Julie Alliance | 1999 | — |
| +1 | K061114 | WDS, Size 2 and Size 2 | Cefla S.C.R.L. | 2006 | — |
| +1 | K080738 | Dentron Sensor | Dentron Systems, LLC | 2008 | — |
| +2 | K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | 2009 | — |
| +3 | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| +4 | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2024 | 1 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 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, K061114 (Cefla S.C.R.L., 2006) has gone furthest, with 5 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.
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?
1) The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film. 2) This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, upon radiation exposure, and by means of the imaging acquisition software provi automatically captures the images into a computer for…
Read the full statement (125 words)
1) The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.
2) This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, upon radiation exposure, and by means of the imaging acquisition software provi automatically captures the images into a computer for viewing, storage and printing.
3)Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.
4) Similar devices have been in use in the USA since 1989, and are now well accepted by Dentists.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990002: Quickray DSX 730.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990002
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