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Basic Information
- Primary DI
- 03760290230125
- Basic UDI-DI Code
- B-03760290230125
- Reference
- SDX0365V1.0
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- DYN'R
Additional Description
The SDX System and Gating Module is intended to be used in conjunction with a Radiation Therapy system (imaging & treatment) requiring operator intervention to start & stop radiation. The necessity to have operator intervention allows for complete control by the operator, however such configurations induces human reaction-time lags between the radiation therapy operator & the SDX operator. The Gating Module is intended to facilitate the interface between operators, whilst ensuring at all times the operators have complete control & maintain the final decision in imaging & treatment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11019099 | VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER |
Certificates
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).