FDA Registration
Active
🇯🇵 Japan
SONIALVISION G4
Reg #: 3003927316
·
FEI: 3003927316
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHIMANE SHIMADZU CORPORATION
- Registration Number
- 3003927316
- FEI Number
- 3003927316
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2698 NAOE, HIKAWA-CHO
- City
- IZUMO Shimane
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K142341
Owner / Operator
- Firm Name
- Shimadzu Corporation
- Operator Number
- 8030233
- Address
- 1 NISHINOKYO KUWABARA-CHO
- City
- KYOTO-SHI
- State
- JP-26
- Postal Code
- 604-8511
- Country
- JP
US Agent
- Business Name
- Shimadzu Medical Systems
- Contact Name
- Johnny Goossens
- Address
- 3645 N Lakewood Blvd
- City
- Long Beach
- State
- CA
- ZIP
- 90808
- Country
- US
- [email protected]
- Phone
- 310 2178855 ext. 174
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2016-03-02 |
Proprietary Names
SONIALVISION G4
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)