FDA Registration
Active
🇺🇸 United States
MEVION S250i Proton Therapy System / MEVION S250mx Multi-Room Proton Therapy System
Reg #: 3007087027
·
FEI: 3007087027
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEVION MEDICAL SYSTEMS, INC.
- Registration Number
- 3007087027
- FEI Number
- 3007087027
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 300 Foster St
- City
- Littleton
- State
- MA
- ZIP
- 01460
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172848
Owner / Operator
- Firm Name
- Mevion Medical Systems, Inc.
- Operator Number
- 10041144
- Address
- 300 Foster Street
- City
- Littleton
- State
- MA
- Postal Code
- 01460
- Country
- US
- Correspondent
- Ping Hu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2018-01-09 |
Proprietary Names
MEVION S250i Proton Therapy System / MEVION S250mx Multi-Room Proton Therapy System
Establishment Types
Manufacture Medical Device