Rayscan Α+, Vision 16, RCT700
The RCT700 is an extraoral dental X-ray system for examining teeth, jaws and oral structures. It provides panoramic imaging and cone-beam CT for implant planning and other dental…
The RCT700 is an extraoral dental X-ray system for examining teeth, jaws and oral structures. It provides panoramic imaging and cone-beam CT for implant planning and other dental examinations, with optional cephalometric imaging for orthodontic assessment. Use is by or on the order of a dentist.
A rotating arm carries an X-ray source and detector around the patient. Images acquired from different angles are reconstructed into a three-dimensional view of hard tissues such as bone and teeth. Panoramic examinations use a narrow beam to produce a two-dimensional overview.
Positioning and Options
The system adjusts to patient height and uses a computer to reconstruct and display images. Available configurations differ in cephalometric capability, and a model-scan option produces cone-beam CT images of dental models. Patient imaging is recommended for ages over five years.
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) | K182614 |
| Record published | 2025-08-25 |
| Record revised | 2026-04-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RCT700 | 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 |
| Rayscan α-Expert3D | RAY Co., Ltd., | 9 |
| Orthophos SL | Sirona Dental Systems Gmbh | 9 |
| Orthophos XG | Sirona Dental Systems Gmbh | 9 |
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.