510(k) · Cleared
ClearedRAYSCAN a-Expert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ray Co., Ltd. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Apr 18, 2024 as substantially equivalent to K142058 (Ray Co., Ltd., 2015) after a 259-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Apr 18, 2024
- Review
- 259 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K972312 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 5 generations backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- 4 generations backK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- 3 generations backK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
- 2 generations backK131693 Rayscan a-ExpertRay Co., Ltd. · 2013
- 1 generation backK142058 Rayscan a-ExpertRay Co., Ltd. · 2015
- This deviceK232325 RAYSCAN a-ExpertRay Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −5 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| −4 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| −3 | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| −2 | K131693 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| −1 | K142058 | Rayscan a-Expert | Ray Co., Ltd. | 2015 | — |
| 0 (this device) | K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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.
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K142058.
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. 2024, 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 RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232325: RAYSCAN a-Expert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232325
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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