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 22, 2015 as substantially equivalent to K122918 (Ray Co., Ltd., 2013) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.
- Decided
- Apr 22, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K972312 (1997). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 4 generations backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- 3 generations backK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- 2 generations backK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
- 1 generation backK131693 Rayscan a-ExpertRay Co., Ltd. · 2013
- This deviceK142058 Rayscan a-ExpertRay Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
- Descendant · cites it directly · 0 of its ownK232325 RAYSCAN a-ExpertRay Co., Ltd. · 2024
- Descendant · 2 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 3 of 3 · See all- K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018 · cites it directly1descendant
- K232325RAYSCAN a-ExpertRay Co., Ltd. · 2024 · cites it directly0descendants
- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −4 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| −3 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| −2 | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| −1 | K131693 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| 0 (this device) | K142058 | Rayscan a-Expert | Ray Co., Ltd. | 2015 | — |
| +1 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018 | — |
| +1 | K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K122918 | Rayscan a-ExpertSummary page 6…N α–Expert RAYSCAN α–Expert Manufacturer RAY Co., Ltd RAY Co., Ltd K122918 K131693 510(K) Number Traditional 510k Special… | 2013 |
| * | K131693 | Rayscan a-ExpertSummary page 6…AN α–Expert Manufacturer RAY Co., Ltd RAY Co., Ltd K122918 K131693 510(K) Number Traditional 510k Special 510k Classification name… | 2013 |
What descends from it? (3)
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 18 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K181297 (Hdx Will Corp., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K122918.
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. 2015, 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 Į- Expert Dental X-Ray System is an extraoral 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 as stated in the FDA summary.
https://510kreport.com/device/K142058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142058: 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/K142058
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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