FDA Registration
Active
🇨🇦 Canada
EPIQ Series Diagnostic Ultrasound System
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
5
Proprietary Names
25
Establishment Types
1
Classifications
5
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
- K211597
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 |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-09-20 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-09-20 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2021-09-20 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2021-09-20 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-09-20 |
Proprietary Names
EPIQ Series Diagnostic Ultrasound System
Affiniti 30 Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
EPIQ Elite Diagnostic Ultrasound System
Affiniti 30 Diamond Select Ultrasound System
EPIQ 5W Ultrasound System
Affiniti CVx Ultrasound System
EPIQ 7 Ultrasound System
Affiniti Series Diagnostic Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
EPIQ CVx Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
EPIQ 7W Ultrasound System
EPIQ CVxi Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
Affiniti 50 Ultrasound System
EPIQ 5 Ultrasound System
Affiniti 70 Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device