FDA Registration
Active
🇯🇵 Japan
CT Brain Perfusion for Ziostation
Reg #: 3006621332
·
FEI: 3006621332
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ZIOSOFT, INC.
- Registration Number
- 3006621332
- FEI Number
- 3006621332
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Mitakokusai Bldg., 1-4-28 Mita
- City
- Minato-ku Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K083084
Owner / Operator
- Firm Name
- Ziosoft, Inc.
- Operator Number
- 10054027
- Address
- Mitakokusai Bldg., 1-4-28 Mita
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 108-0073
- Country
- JP
- Correspondent
- Hajime Kaneko
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-02-02 |
Proprietary Names
CT Brain Perfusion for Ziostation
Establishment Types
Manufacture Medical Device