FDA Registration
Active
🇺🇸 United States
Affiniti 50 Circular Edition Ultrasound System
Reg #: 3017894900
·
FEI: 3017894900
·
Expires 2025
Products
5
Proprietary Names
37
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 3017894900
- FEI Number
- 3017894900
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233788
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 |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-03-25 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-03-25 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-03-25 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2024-03-25 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-03-25 |
Proprietary Names
Affiniti 50 Circular Edition Ultrasound System
EPIQ 5C Diagnostic Ultrasound System
Affiniti 30 Diamond Select Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
EPIQ 7G Diagnostic Ultrasound System
EPIQ 7W Diagnostic Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
Affiniti 50W Diagnostic Ultrasound System
EPIQ Diagnostic Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
EPIQ CVx Diagnostic Ultrasound System
EPIQ Elite Diagnostic Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
Affiniti 70C Diagnostic Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
EPIQ 5 Diagnostic Ultrasound System
Affiniti 70 Diagnostic Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
EPIQ CVx Diamond Select Ultrasound System
Affiniti 50G Diagnostic Ultrasound System
Affiniti 50 Diagnostic Ultrasound System
EPIQ 5W Diagnostic Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
Affiniti 70G Diagnostic Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
Affiniti CVx Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
Affiniti 50C Diagnostic Ultrasound System
EPIQ Elite W Diagnostic Ultrasound System
EPIQ 7 Diagnostic Ultrasound System
Affiniti Series Diagnostic Ultrasound System
EPIQ 7C Diagnostic Ultrasound System
Affiniti 70W Diagnostic Ultrasound System
EPIQ CVxi Diagnostic Ultrasound System
EPIQ 5G Diagnostic Ultrasound System
EPIQ Elite Diamond Select Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility