FDA Registration
Active
🇺🇸 United States
PAIGE.AI, INC
Reg #: 3017125738
·
FEI: 3017125738
·
Expires 2026
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PAIGE.AI, INC
- Registration Number
- 3017125738
- FEI Number
- 3017125738
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 33 Irving Place, 3rd Floor
- City
- New York
- State
- NY
- ZIP
- 10003
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241273
Owner / Operator
- Firm Name
- Paige.AI, Inc
- Operator Number
- 10076458
- Address
- 33 Irving Place, 3rd Floor
- City
- New York
- State
- NY
- Postal Code
- 10003
- Country
- US
- Correspondent
- Bensu Altan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Whole Slide Imaging System | PSY | Class 2 | Pathology | No | 2025-12-18 |
| Digital Pathology Image Viewing And Management Software | QKQ | Class 2 | Pathology | No | 2025-12-18 |
| Software Algorithm Device To Assist Users In Digital Pathology | QPN | Class 2 | Pathology | No | 2021-09-25 |
Proprietary Names
FullFocus
Paige Prostate Detect
Establishment Types
Manufacture Medical Device