Dental Cone-Beam Computed Tomography
The Dental Cone-beam Computed Tomography system produces two-dimensional panoramic and cephalometric X-ray images and three-dimensional images of the dental, oral and maxillofacial region.…
The Dental Cone-beam Computed Tomography system produces two-dimensional panoramic and cephalometric X-ray images and three-dimensional images of the dental, oral and maxillofacial region. Healthcare professionals use model iDT901X1 as diagnostic support for adults and pediatric patients within its stated size limits.
The system combines a supporting frame, an X-ray generator, an image receptor and an image processing workstation. The generator includes the X-ray tube head, tube and collimator. A computer, monitor and software workstation provide image processing and display.
Patient Size Limits
The device is not intended for patients below approximately 21 kg in weight and 113 cm in height. These measurements correspond approximately to an average five-year-old child.
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 | Yian Medical Technology (Haining) Co., Ltd., China |
|---|---|
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K232710 |
| Record published | 2024-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| iDT901X1 | 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 |
|---|---|
| K251642 | 2025-06-27 |
| K240855 | 2024-04-25 |
| K232710 | 2024-01-09 |
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.