FDA Registration
Active
🇫🇮 Finland
Eclipse Treatment Planning System v 15.6
Reg #: 3003793371
·
FEI: 3003793371
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Varian Medical Systems Finland 0y
- Registration Number
- 3003793371
- FEI Number
- 3003793371
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Alvar Aallon katu 5C
- City
- Helsinki Uusimaa
- Country
- FI
Regulatory Submissions
- 510(k) Number
- K181145
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
US Agent
- Business Name
- VARIAN MEDICAL SYSTEMS, INC
- Contact Name
- Ali Rezaei
- Address
- 3100 Hansen Way
- City
- Palo Alto
- State
- CA
- ZIP
- 94304
- Country
- US
- [email protected]
- Phone
- 650 4246545
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2018-05-22 |
Proprietary Names
Eclipse Treatment Planning System v 15.6
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198