FDA Registration
Active
🇬🇧 United Kingdom
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
Reg #: 3013204397
·
FEI: 3013204397
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Modality Group Ltd
- Registration Number
- 3013204397
- FEI Number
- 3013204397
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 56 Hayhill Industrial Estate, 47 Hayhill
- City
- Barrow upon Soar Leicestershire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K142395
Owner / Operator
- Firm Name
- Modality Group Ltd
- Operator Number
- 10053163
- Address
- Fosse House, 20 Prince William Road
- City
- Loughborough
- State
- Leicestershire
- Postal Code
- LE11 5GU
- Country
- GB
- Correspondent
- Carl Bowtell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2017-06-08 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2017-06-08 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2017-06-08 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2017-06-08 |
Proprietary Names
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
Establishment Types
Export Device to the United States But Perform No Other Operation on Device