FDA Registration
Active
🇯🇵 Japan
ONIS-PACS
Reg #: 3014980441
·
FEI: 3014980441
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIGITALCORE
- Registration Number
- 3014980441
- FEI Number
- 3014980441
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Setagaya-Ku Kinuta 5-8-31, Ginga M2
- City
- Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K181318
Owner / Operator
- Firm Name
- DIGITALCORE
- Operator Number
- 10058993
- Address
- Setagaya-Ku Kinuta 5-8-31, Ginga M2
- City
- Tokyo
- State
- JP-13
- Postal Code
- 1570073
- Country
- JP
- Correspondent
- Cedric LEMOIGNE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-11-19 |
Proprietary Names
ONIS-PACS
Establishment Types
Manufacture Medical Device