FDA Registration
Active
🇺🇸 United States
Koios Medical, Inc.
Reg #: 3010119782
·
FEI: 3010119782
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Koios Medical, Inc.
- Registration Number
- 3010119782
- FEI Number
- 3010119782
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 242 West 38th Street, 14th Floor
- City
- New York
- State
- NY
- ZIP
- 10018
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212616
Owner / Operator
- Firm Name
- Koios Medical, Inc.
- Operator Number
- 10054621
- Address
- 242 West 38th Street, 14th Floor
- City
- New York
- State
- NY
- Postal Code
- 10018
- Country
- US
- Correspondent
- Graham Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2021-12-29 |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | Class 2 | Radiology | No | 2021-12-29 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-10-03 |
Proprietary Names
Koios DS
Koios DS Breast
Establishment Types
Manufacture Medical Device