510(k) · Cleared
ClearedRayscan a-Expert 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ray Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 12, 2013 as substantially equivalent to K111152 (Villa Sistemi Medicali S.P.A., 2011) after a 169-day review. Its family tree reaches back 5 generations to 1997. 24 later devices descend from it.
- Decided
- Mar 12, 2013
- Review
- 169 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K973598 (1997). 16 ancestors in all, the oldest K961826 (1996). 24 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 3 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 2 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 1 generation backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- This deviceK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · cites it directly · 23 of its ownK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- Descendant · cites it directly · 22 of its ownK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK160525 RCT700Ray Co., Ltd. · 2016
- Descendant · 2 generations on · 10 of its ownK181452 RCT800Ray Co., Ltd. · 2018
- Descendant · 2 generations on · 9 of its ownK160140 DENTRIa seriesHdx Will Corp. · 2016
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K131695Rayscan a-Expert 3DRay Co., Ltd. · 2013 · cites it directly23descendants
- K142247Rayscan a-Expert 3DRay Co., Ltd. · 2015 · cites it directly22descendants
- K160525RCT700Ray Co., Ltd. · 2016 · cites it directly11descendants
- K181452RCT800Ray Co., Ltd. · 2018 · 2 generations on10descendants
- K160140DENTRIa seriesHdx Will Corp. · 2016 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −3 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −2 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −1 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| 0 (this device) | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +1 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| +1 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| +1 | K160525 | RCT700 | Ray Co., Ltd. | 2016 | — |
| +2 | K181452 | RCT800 | Ray Co., Ltd. | 2018 | — |
| +2 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K111152 | Rotograph Evo 3DSummary page 1…y system Classification x-ray, tomography, computed, dental (21 CFR 892.1750) Class: 11 Product code : OAS Panel : Radiology Predicate device Rotagraph EVO 3D(K111152) page 1 /6… | 2011 |
What descends from it? (24)
See all 243 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 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K131695 (Ray Co., Ltd., 2013) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K111152.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
RAYSCAN a - Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
2D Image is obtained using the standard narrow beam technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122981: Rayscan a-Expert 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122981
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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