FDA Registration
Active
🇨🇳 China
Truesight
Reg #: 3007675950
·
FEI: 3007675950
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD.
- Registration Number
- 3007675950
- FEI Number
- 3007675950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.177-2, Chuangxin Road, Hunnan District
- City
- Shen Yang Liaoning
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K090178
Owner / Operator
- Firm Name
- Neusoft Positron Medical Systems Co LTD
- Operator Number
- 10029410
- 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, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2009-05-11 |
Proprietary Names
Truesight
Attrius
Attrius L
Establishment Types
Manufacture Medical Device