FDA Registration
Active
🇺🇸 United States
Ezra Plexo
Reg #: 3027347389
·
FEI: 3027347389
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EZRA AI, INC.
- Registration Number
- 3027347389
- FEI Number
- 3027347389
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 287 Park Ave South, Suite 615
- City
- New York
- State
- NY
- ZIP
- 10010
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192969
Owner / Operator
- Firm Name
- Ezra AI, Inc.
- Operator Number
- 10087985
- Address
- 287 Park Ave South, Suite 615
- City
- New York
- State
- NY
- Postal Code
- 10010
- Country
- US
- Correspondent
- Emi Gal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-09-11 |
Proprietary Names
Ezra Plexo
Ezra Prostate AI
Establishment Types
Manufacture Medical Device