Eu Mdd
Eu Md Class 2b
On The Market
🇺🇸 United States
Mevion S250i
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 00864366000124
- Basic UDI-DI Code
- B-00864366000124
- Reference
- S250i
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Mevion Medical Systems, Inc.
Additional Description
The MEVION S250i is a proton beam radiotherapy system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam set with a prescribed dose and dose distribution to a prescribed patient based target, consistent with the facility’s Treatment Planning System (TPS).
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z11011001 | PROTON THERAPY SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | Mevion S250i | BSI Group The Netherlands B.V. | Expired |
Available In Countries
🇳🇱 Netherlands
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).
Horizontal Steam Sterilizer
Device
EU MDD
·
Eu Md Class 2b
·PROHS Equipamento Hospitalar e Serviços Associados S.A.·On the market·10 countries
Adacolumn
Device
EU MDD
·
Eu Md Class 2b
·JIMRO Co., Ltd.·On the market·9 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·8 countries
Echopulse
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·7 countries
Sonovein
Device
EU MDD
·
Eu Md Class 2b
·Theraclion·On the market·6 countries
HANAROSTENT®
Device
EU MDD
·
Eu Md Class 2b
·M.I.Tech Co., Ltd·On the market·32 countries