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 Mar 15, 2013 as substantially equivalent to K033073 (Sirona Dental Systems GmbH, 2003) after a 172-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Mar 15, 2013
- Review
- 172 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972312 (1997). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 2 generations backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- 1 generation backK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- This deviceK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK131693 Rayscan a-ExpertRay Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK142058 Rayscan a-ExpertRay Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK232325 RAYSCAN a-ExpertRay Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark…De Gotzen S.R.L. · 2020
Most influential descendants
Showing 5 of 5 · See all- K131693Rayscan a-ExpertRay Co., Ltd. · 2013 · cites it directly4descendants
- K142058Rayscan a-ExpertRay Co., Ltd. · 2015 · cites it directly3descendants
- K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018 · 2 generations on1descendant
- K232325RAYSCAN a-ExpertRay Co., Ltd. · 2024 · 2 generations on0descendants
- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −2 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| −1 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| +1 | K131693 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| +1 | K142058 | Rayscan a-Expert | Ray Co., Ltd. | 2015 | — |
| +2 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018 | — |
| +2 | K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024 | — |
| +3 | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy… | De Gotzen S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K033073 | Orthophos XG DS/CephSummary page 1…tion Extraoral source dental X-ray system (21 CFR 872.1800) Class: 11 Product code : MUH Panel : Radiology Predicate device Orthophos XGPUS DS/Ceph Dental X-ray system(K033073) Description RAYSCAN a- Expert is designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the… | 2003 |
What descends from it? (5)
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131693 (Ray Co., Ltd., 2013) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K033073.
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. 2013, 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- Expert Dental X-Ray System is an extruoral source dental panoramic and
optional cephalometric X-ray system intended to produce X-rays for dental radiographic
examination and diagnosis of diseases of the teeth, jaw, and oral structures.
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/K122918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122918: 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/K122918
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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