FDA Registration
Active
🇰🇷 South Korea
Atal 8C
Reg #: 3008304180
·
FEI: 3008164200
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PixxGen Corporation
- Registration Number
- 3008304180
- FEI Number
- 3008164200
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5F Smart Bay, 123, Beolmal-ro, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K113812
Owner / Operator
- Firm Name
- PixxGen Corporation
- Operator Number
- 10035114
- Address
- 28081 Hastings
- City
- Mission Viejo
- State
- CA
- Postal Code
- 92692
- Country
- US
- Correspondent
- John F Ross
US Agent
- Business Name
- Private
- Contact Name
- JOHN ROSS
- Address
- 35768 West Santa Monica Avenue
- City
- Maricopa
- State
- AZ
- ZIP
- 85138
- Country
- US
- [email protected]
- Phone
- 949 9295910
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2013-03-06 |
Proprietary Names
Atal 8C
Atal 8
Establishment Types
Manufacture Medical Device