FDA Registration
Active
🇨🇦 Canada
dS Flex Coil S (3T), dS Flex Coil M (1.5T), dS Flex Coil M (3T), dS Flex Coil L (1.5T)
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K123492
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
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2013-02-25 |
Proprietary Names
dS Flex Coil S (3T), dS Flex Coil M (1.5T), dS Flex Coil M (3T), dS Flex Coil L (1.5T)
dS Flex Coil L (3T)
dS Anterior 1.5T
dS FLEX-M 1.5T
dS Base 1.5T
dS Anterior Coil (3T), dS Base Coil (1.5T), dS Base Coil (3T), dS Head-Neck Coil (1.5T)
dS Head-Neck Coil (3T), dS Head Coil (1.5T), dS Head Coil (3T), dS Flex Coil S (1.5T)
dS Anterior Coil (1.5T)
1.5T AND 3T GENERAL PURPOSE FLEX COILS
FRU, COIL ASSY, PHC 1.5T 16CH
dS FLEX-L 3T
dS Anterior 3T
dS Head 1.5T
dS FLEX-S 1.5T
dS Base 3T
dS FLEX-L 1.5T
dS HeadNeck 3T
dS Head 3T
dS FLEX-M 3T
dS FLEX-S
dS HeadNeck 1.5T
Establishment Types
Export Device to the United States But Perform No Other Operation on Device