Data / Medical devices / United States / Pathwai, Inc
Pathwai, Inc: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Pathwai, Inc is registered with the FDA (registration 3046433998) in New York, NY, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3046433998
- Address
- 189 W 89th Street Apt 6E, New York, NY, United States, 10024
- Owner or operator
- Pathwai, Inc (10096052)
- Roles
- Manufacturer
- First device listed
- June 12, 2026
- Registered through
- 2026
- Brand names listed
- EchoNext
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aortic Stenosis Machine Learning-Based Notification Software | SII | 2 | Manufacturer | accessdata.fda.gov |
| Cardiac Hypertrophy Machine Learning-Based Notification Software | SIK | 2 | Manufacturer | accessdata.fda.gov |
| Cardiovascular Machine Learning-Based Notification Software | QXO | 2 | Manufacturer | accessdata.fda.gov |
| Pulmonary Hypertension Machine Learning-Based Notification Software | SAT | 2 | Manufacturer | accessdata.fda.gov |
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | 2 | Manufacturer | accessdata.fda.gov |
| Valvular Regurgitation Machine Learning-Based Notification Software | SIJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2026 | K260332 | EchoNext | QXO | Substantially Equivalent | Pathwai, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pulmonary Hypertension Machine Learning-Based Notification Software
- All makers of Reduced Ejection Fraction Machine Learning-Based Notification Software
- All makers of Cardiovascular Machine Learning-Based Notification Software
Updated June 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.