FDA Registration
Active
🇺🇸 United States
XENOVIEW 3T Chest Coil
Reg #: 3010132318
·
FEI: 3010132318
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- POLAREAN, INC.
- Registration Number
- 3010132318
- FEI Number
- 3010132318
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2500 Meridian Pkwy, #175
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212239
Owner / Operator
- Firm Name
- Polarean, Inc.
- Operator Number
- 10087679
- Address
- 2500 Meridian Pkwy, #175
- City
- Durham
- State
- NC
- Postal Code
- 27713
- Country
- US
- Correspondent
- Amanda Morris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2024-11-15 |
Proprietary Names
XENOVIEW 3T Chest Coil
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility