FDA Registration
Active
🇨🇳 China
NEUSOFT MEDICAL SYSTEMS CO., LTD.
Reg #: 3003575350
·
FEI: 3003575350
·
Expires 2026
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEUSOFT MEDICAL SYSTEMS CO., LTD.
- Registration Number
- 3003575350
- FEI Number
- 3003575350
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.177-1 Chuangxin Road, Hunnan District
- City
- SHENYANG Liaoning
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K133373
Owner / Operator
- Firm Name
- NEUSOFT MEDICAL SYSTEMS CO., LTD.
- Operator Number
- 9050318
- Address
- No.177-1 Chuangxin Road, Hunnan District
- City
- Shenyang
- State
- Liaoning
- Postal Code
- 110167
- Country
- CN
US Agent
- Business Name
- NEUSOFT MEDICAL SYSTEMS U.S.A., INC.
- Contact Name
- Thomas P. Buse
- Address
- 14425 Torrey Chase Blvd Suite 100
- City
- Houston
- State
- TX
- ZIP
- 77014
- Country
- US
- [email protected]
- Phone
- 281 4531206
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2014-12-03 |
Proprietary Names
ClearView
NeuViz 128
NeuViz 16 Essence Multi-Slice CT Scanner System
NeuViz 64 In, NeuViz 64 En
NeuViz 64i,NeuViz 64e
Establishment Types
Manufacture Medical Device