Bright CT
This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw joint by placing X-rays and image detection sensors facing each…
This product is a dental computed tomography device designed to obtain images of the patient’s teeth, nasal cavity, and jaw joint by placing X-rays and image detection sensors facing each other to obtain images while rotating around the patient’s central axis, and to analyze while displaying tomography images of the patient’s interest on the screen through computer calculation. In addition, this product includes functions such as reconstructing images and displaying images, modifying images, and storing images as an image manipulation function. It is equipped with a CT (Computational tomography) mode that can acquire a three-dimensional tomography image and a Panoramic mode for acquiring a two-dimensional semi-elliptical flat image, and includes a Cephalo mode used for rear and lateral head photography with a Scan method as an optional specification.
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 | Dentium 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 | Manufacturer |
| 510(k) | K231181 |
| Record published | 2023-12-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICT-R02-2TC | In distribution | |
| ICT-R02-1T | In distribution | |
| ICT-R02-2TS | In distribution | |
| ICT-R02-2T | In distribution | |
| ICT-R02-1TC | In distribution | |
| ICT-R02-2TSC | 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
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.