FDA Registration
Active
🇮🇳 India
Affiniti 30 Diamond Select Ultrasound System
Reg #: 3033527241
·
FEI: 3033527241
·
Expires 2025
Products
5
Proprietary Names
23
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Philips Global Business Services LLP - Ultrasound Business Unit
- Registration Number
- 3033527241
- FEI Number
- 3033527241
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5th Floor, Amar Madhuban Tech Park
- City
- Baner Pune Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K212704
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
- Ondrea Bermudez
- Address
- 3721 Valley Centre Dr
- City
- San Diego
- State
- CA
- ZIP
- 92130
- Country
- US
- [email protected]
- Phone
- 443 3200028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2021-09-27 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2021-09-27 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2021-09-27 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2021-09-27 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2021-09-27 |
Proprietary Names
Affiniti 30 Diamond Select Ultrasound System
EPIQ 7 Diamond Select Ultrasound System
EPIQ 7W Ultrasound System
EPIQ CVx Ultrasound System
Affiniti 70 Diamond Select Ultrasound System
Affiniti CVx Ultrasound System
EPIQ 5W Ultrasound System
EPIQ 5 Ultrasound System
Affiniti 50 Diamond Select Ultrasound System
EPIQ 7 Ultrasound System
EPIQ CVxi Ultrasound System
Affiniti 70 Ultrasound System
Affiniti 50 Ultrasound System
EPIQ Elite Diagnostic Ultrasound System
EPIQ 5 Diamond Select Ultrasound System
Affiniti 30 Circular Edition Ultrasound System
Affiniti 30 Ultrasound System
EPIQ Elite Circular Edition Ultrasound System
Affiniti 70 Circular Edition Ultrasound System
EPIQ CVx Circular Edition Ultrasound System
EPIQ 7 Circular Edition Ultrasound System
EPIQ 5 Circular Edition Ultrasound System
Affiniti 50 Circular Edition Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility