FDA Registration
Active
🇺🇸 United States
CT CoPilot
Reg #: 1226773
·
FEI: 3003405980
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORTECHS LABS, INC.
- Registration Number
- 1226773
- FEI Number
- 3003405980
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5060 Shoreham Place, Suite 240
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161322
Owner / Operator
- Firm Name
- CORTECHS LABS, INC.
- Operator Number
- 9046543
- Address
- 5060 Shoreham Pl., Suite 240
- City
- San Diego
- State
- CA
- Postal Code
- 92122
- Country
- US
- Correspondent
- Kora - Marinkovic
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-05-27 |
Proprietary Names
CT CoPilot
NeuroQuantCT
NeuroAlign CT
Establishment Types
Manufacture Medical Device