RAYQuantum
The RCT600 comparison lists a Scan Ceph configuration alongside CT and panoramic imaging. The filing describes RCT600 as a cone-beam CT and panoramic X-ray system with cephalometric…
The RCT600 comparison lists a Scan Ceph configuration alongside CT and panoramic imaging. The filing describes RCT600 as a cone-beam CT and panoramic X-ray system with cephalometric imaging.
Its indication covers radiographic examination of dento-maxillofacial, sinus and TMJ structures for diagnostic support in adult and pediatric patients.
Cephalometric Use
Cephalometric imaging may also include wrist images to obtain carpus images for growth and maturity assessment in orthodontic treatment. The filing names dentists and other legally qualified health professionals as operators.
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) | K243903 |
| Record published | 2025-04-14 |
| 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 |
|---|---|---|
| Scan Ceph | 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.