Data / Medical devices / United States / Fovia, Inc.
Fovia, Inc.: FDA-registered device maker in Kentfield, CA, United States, 1 510(k) clearance
Fovia, Inc. is registered with the FDA (registration 3036471119) in Kentfield, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036471119
- Address
- 907 Sir Francis Drake Blvd, Kentfield, CA, United States, 94904
- Owner or operator
- Fovia, Inc. (10090605)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 6, 2025
- Registered through
- 2026
- Brand names listed
- aiCockpit AI Viewer, aiCockpit Chest Xray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 26, 2025 | K241546 | aiCockpit AI Viewer | LLZ | Substantially Equivalent | Fovia, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated February 26, 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.