FDA Registration
Active
🇺🇸 United States
Pinnacle3 Radiation Therapy Planning System SmartArc Module
Reg #: 3018004899
·
FEI: 3018004899
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Medical Systems (Cleveland), Inc.
- Registration Number
- 3018004899
- FEI Number
- 3018004899
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3630 SW 47th Avenue
- City
- Gainesville
- State
- FL
- ZIP
- 32608
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090808
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2009-05-19 |
Proprietary Names
Pinnacle3 Radiation Therapy Planning System SmartArc Module
Establishment Types
Manufacture Medical Device