FDA Registration
Inactive
🇺🇸 United States
Pathwai, Inc
·
Expires 2026
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Pathwai, Inc
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 189 W 89th Street, Apt 6E
- City
- New York
- State
- NY
- ZIP
- 10024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260332
Owner / Operator
- Firm Name
- Pathwai, Inc
- Operator Number
- 10096052
- Address
- 32 Horizon Dr
- City
- Danville
- State
- PA
- Postal Code
- 17821
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| SIK | No | 2026-06-12 | |||
| Pulmonary Hypertension Machine Learning-Based Notification Software | SAT | Class 2 | Cardiovascular | No | 2026-06-12 |
| SIJ | No | 2026-06-12 | |||
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | Class 2 | Cardiovascular | No | 2026-06-12 |
| Cardiovascular Machine Learning-Based Notification Software | QXO | Class 2 | Cardiovascular | No | 2026-06-12 |
| SII | No | 2026-06-12 |
Proprietary Names
EchoNext
Establishment Types
Manufacture Medical Device