FDA Registration
Active
🇺🇸 United States
EPIQ Diagnostic Ultrasound Systems
Reg #: 2518586
·
FEI: 2518586
·
Expires 2025
Products
4
Proprietary Names
14
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Philips Ultrasound LLC
- Registration Number
- 2518586
- FEI Number
- 2518586
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Echo Dr
- City
- Reedsville
- State
- PA
- ZIP
- 17084
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201012
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 | 2020-05-20 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2020-05-20 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-05-20 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-05-20 |
Proprietary Names
EPIQ Diagnostic Ultrasound Systems
Affiniti Diagnostic Ultrasound Systems
Cx50 Diagnostic Ultrasound System
Lumify Diagnostic Ultrasound System
QLAB Advanced Quantification Software
Sparq Diagnostic Ultrasound System
EPIQ Circular Edition Diagnostic Ultrasound System
Sparq Diamond Select Diagnostic Ultrasound System
Lumify Diamond Select Diagnostic Ultrasound System
Sparq Circular Edition Diagnostic Ultrasound System
Affiniti Circular Edition Diagnostic Ultrasound System
CX50 Diamond Select Diagnostic Ultrasound System
CX50 Circular Edition Diagnostic Ultrasound System
Lumify Circular Edition Diagnostic Ultrasound System
Establishment Types
Manufacture Medical Device