Rayscan Α-Expert
RAYSCAN Alpha Expert is an extraoral dental X-ray system for panoramic examination of teeth, jaws and oral structures, with cephalometric options. Its applications include implantology and…
RAYSCAN Alpha Expert is an extraoral dental X-ray system for panoramic examination of teeth, jaws and oral structures, with cephalometric options. Its applications include implantology and temporomandibular-joint studies. It supports adult and pediatric imaging; the manufacturer recommends diagnostic exposure for patients older than five years.
A rotating C-arm carries the X-ray source and detector. The system combines data acquired from different angles to form panoramic images using a narrow beam. Configurations include panoramic-only, scanning cephalometry, and standard or large one-shot cephalometry.
Detector Configurations
OCL uses a large one-shot cephalometric detector, including FXRD-1717VA, while OCS uses a standard one-shot detector, including FXDD-1012CA. Panoramic detector options include C10500D. Images are compatible with DICOM 3.0, and patient positioning accommodates standing or wheelchair use.
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Orich Medical Equipment (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 5 |
| Ningbo Runyes Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Shenzhen Xpectvision Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 4 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shanghai Handy Medical Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | RAY Co., Ltd.,, South Korea |
|---|---|
| FDA product code | MUH |
| Device type | System, X-Ray, Extraoral Source, Digital |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1800 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K232325 |
| Record published | 2024-04-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OCL-Pano(Pluto600X)+FXRD-1717VA | In distribution | |
| OCS-Pano(C10500D)+FXDD-1012CA | In distribution | |
| Pano(Pluto0600X) | In distribution | |
| OCL-Pano(C10500D)+FXRD-1717VA | In distribution | |
| OCS-Pano(Pluto0600X)+FXDD-1012CA | In distribution | |
| SC-Pano(C10500D)+Scan Ceph(XID-C24DC) | In distribution | |
| SC-Pano(Pluto0600X)+Scan Ceph(XID-C24DC) | In distribution | |
| Pano(C10500D) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Schick Elite | Sirona Dental, Inc. | 38 |
| Schick Wifi | Sirona Dental, Inc. | 31 |
| Midmark Intraoral Digital Sensor | Midmark Corporation | 26 |
| Xios XG Wifi | Sirona Dental, Inc. | 25 |
| Midmark OptiMax Digital Sensor System | Midmark Corporation | 24 |
| Gendex GXS-700™ intraoral sensor | Gendex Corp. | 19 |
| Genoray | Genoray Co., Ltd. | 14 |
| X-Mind trium | DE Götzen SRL | 12 |
| X-Mind optima 3D | DE Götzen SRL | 12 |
| Dexis Titanium Sensor Kit | Dental Imaging Technologies Corporation | 11 |
| Xios XG Select | Sirona Dental, Inc. | 11 |
| Planmeca ProMax | Planmeca Oy | 11 |
Showing 12 of 279. All products under System, X-Ray, Extraoral Source, Digital
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232325 | 2024-04-18 |
| K160788 | 2016-04-15 |
| K142058 | 2015-04-22 |
| K131693 | 2013-11-01 |
| K122918 | 2013-03-15 |
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.