FDA Registration
Active
🇯🇵 Japan
PreXion3D Expedition
Reg #: 3009259056
·
FEI: 3009259056
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PREXION CORPORATION
- Registration Number
- 3009259056
- FEI Number
- 3009259056
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1-14-1, Kandasuda-cho
- City
- Chiyoda-ku Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K232166
Owner / Operator
- Firm Name
- PreXion Corporation
- Operator Number
- 10052846
- Address
- 1-14-1, Kandasuda-cho
- City
- Chiyoda-ku
- State
- Tokyo
- Postal Code
- 101-0041
- Country
- JP
- Correspondent
- Kenji Tanaka
US Agent
- Business Name
- PreXion,Inc.
- Contact Name
- Keith Huang
- Address
- 181 Metro Drive, Suite 190
- City
- San Jose
- State
- CA
- ZIP
- 95110
- Country
- US
- [email protected]
- Phone
- 650 2120300
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2023-09-11 |
Proprietary Names
PreXion3D Expedition
Establishment Types
Manufacture Medical Device