FDA Registration
Active
🇫🇷 France
3Sc-RS
Reg #: 3003594449
·
FEI: 3003594449
·
Expires 2025
Products
4
Proprietary Names
13
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PARALLEL DESIGN SAS
- Registration Number
- 3003594449
- FEI Number
- 3003594449
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1090 Route des Cretes
- City
- VALBONNE Alpes-Maritimes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K250543
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-06-02 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-06-02 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-06-02 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-06-02 |
Proprietary Names
3Sc-RS
C1-5-RS
IC9-RS
RIC5-9A-RS
Voluson Performance 16
RAB6-RS
RAB2-6-RS
Voluson Performance 18
4C-RS
IC9B-RS
12L-RS
12S-RS
9L-RS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility