ULTRA 100
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Basic Information
- Primary DI
- 08809661400028
- Basic UDI-DI Code
- B-08809661400028
- Reference
- EBF-U10-001
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- ECORAY Co., Ltd.
Additional Description
A diagnostic system to obtain the information necessary for the diagnosis of the patient through the anatomical structure of human body obtained by a film or an image processing (workstation) after process of examination using radiation exposure with cassette IP, CR or DR (Portable flat panel). (When using ULTRA 100 with the mobile support device, it is able to be used as a mobile x-ray equipment, but also it was intended and designed Portable X-ray to be carried easily and used in any place such as hospitals, clinics and etc in order to achieve X-ray images easily)
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11039016 | MOBILE RADIOGRAPHIC UNITS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 10114-2017-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).