Rayscan α-Expert3D
RAYSCAN alpha-Expert3D is a dental X-ray system that produces panoramic images and three-dimensional cone beam CT views. It images teeth, jaws and oral structures for dental assessment,…
RAYSCAN alpha-Expert3D is a dental X-ray system that produces panoramic images and three-dimensional cone beam CT views. It images teeth, jaws and oral structures for dental assessment, implant planning and temporomandibular joint studies.
A rotating C-arm carries the X-ray source and detector around the patient. Software reconstructs projections from different angles into a three-dimensional volume for viewing on an imaging workstation.
Configuration
Cephalometric imaging is available in the corresponding system configurations. The system is intended for adult and pediatric patients, with imaging configuration and detector options selected for the examination. The manufacturer recommends diagnostic X-ray exposure for patients older than five.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Yian Medical Technology (Haining) Co., Ltd. | Jiaxing | Zhejiang | Specification developer | 1 |
| Changzhou Finno Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | RAY Co., Ltd.,, South Korea |
|---|---|
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K232287 |
| Record published | 2023-09-07 |
| Record revised | 2023-04-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M3DL-CT,Pano(FXDD-0606CA)+FXRD-1717VA | In distribution | |
| M3DS-CT,Pano(FXDD-0606CA)+FXDD-1012CA | In distribution | |
| M3DL-CT,Pano+One shot Ceph(PaxScan 4336X) | In distribution | |
| SM3D-CT,Pano(FXDD-0606CA)+Scan Ceph(XID-C24DC) | In distribution | |
| M3DL-CT,Pano+One shot Ceph(1717SCC) | In distribution | |
| 3D-CT,Pano | In distribution | |
| SM3D-CT,Pano+Scan Ceph(XID) | In distribution | |
| M3DS-CT,Pano+One Shot Ceph(PaxScan 2530C) | In distribution | |
| 3D-CT,Pano(FXDD-0606CA) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rayscan | RAY Co., Ltd., | 52 |
| Rayscan Studio | RAY Co., Ltd., | 21 |
| Dental CT Scanner AXR | Alliage S/A Indústrias Médico Odontológica | 15 |
| PaX-i3D Green | Vatech Co., Ltd. | 14 |
| Orthopantomograph™ OP 3D | Palodex Group OY | 11 |
| Sleeve for extraoral X-Ray devices | Sirona Dental Systems Gmbh | 11 |
| SXR / Saevo | Alliage S/A Indústrias Médico Odontológica | 11 |
| X-Mind trium | DE Götzen SRL | 10 |
| Genoray | Genoray Co., Ltd. | 9 |
| Orthophos SL | Sirona Dental Systems Gmbh | 9 |
| Orthophos XG | Sirona Dental Systems Gmbh | 9 |
| PaX-i3D | Vatech Co., Ltd. | 8 |
Showing 12 of 110. All products under X-Ray, Tomography, Computed, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260462 | 2026-04-09 |
| K251798 | 2025-11-25 |
| K243903 | 2025-03-12 |
| K232287 | 2023-08-31 |
| K230753 | 2023-04-11 |
| K213226 | 2021-11-29 |
| K192737 | 2019-10-22 |
| K190812 | 2019-04-24 |
| K182805 | 2018-12-14 |
| K182614 | 2018-10-16 |
| K181452 | 2018-07-27 |
| K160525 | 2016-06-20 |
| K142247 | 2015-04-17 |
| K131695 | 2013-11-01 |
| K122981 | 2013-03-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.