Data / Medical devices / United States / Ezra Ai, Inc.
Ezra Ai, Inc.: FDA-registered device maker in New York, NY, United States, 3 510(k) clearances
Ezra Ai, Inc. is registered with the FDA (registration 3027347389) in New York, NY, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027347389
- Address
- 287 Park Ave South Suite 615, New York, NY, United States, 10010
- Owner or operator
- Ezra AI, Inc. (10087985)
- Roles
- Manufacturer
- First device listed
- May 10, 2023
- Registered through
- 2026
- Brand names listed
- Ezra Flash, Ezra Plexo, Ezra Prostate AI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| January 2, 2025 | K242334 | Ezra Flash | QIH | Substantially Equivalent | Ezra Ai, Inc. | accessdata.fda.gov |
| April 13, 2023 | K230264 | Ezra Flash | LLZ | Substantially Equivalent | Ezra Ai, Inc. | accessdata.fda.gov |
| July 10, 2020 | K192969 | Ezra Plexo Software | QIH | Substantially Equivalent | Ezra Ai, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated January 2, 2025. 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.