Basic Information
- Primary DI
- 08800000995618
- Basic UDI-DI Code
- B-08800000995618
- Reference
- T2-CS
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- OSSTEM IMPLANT CO.,LTD
Additional Description
“T2-CS”, a dental radiographic imaging system, consists of three image acquisition modes; panoramic, cephalometric and cone beam computed tomography. Specifically designed for dental radiography of the teeth or jaws, “T2-CS” are a complete dental X-ray system equipped with X-ray tube, generator and dedicated detector for dental panoramic, cephalometric and cone beam computed tomographic radiography. The dental CBCT system is based on digital X-ray detector. CT detector is used to capture radiographic diagnostic images of oral anatomy in 3D for dental treatment such as oral surgery or implant. The device can also be operated as the panoramic and cephalometric dental X-ray system based on X-ray detector.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11030607 | COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 9746-2017-CE-KOR-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).