Data / Medical devices / United States / Artera
Artera: FDA-registered device maker in Los Altos, CA, United States, 2 510(k) clearances
Artera is registered with the FDA (registration 3029787717) in Los Altos, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 4, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3029787717
- Address
- 108 1st St, Los Altos, CA, United States, 94022
- Owner or operator
- Artera (10093385)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- May 8, 2025
- Registered through
- 2027
- Brand names listed
- ArteraAI Breast, ArteraAI Prostate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis | SHW | 2 | Manufacturer | accessdata.fda.gov |
| Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis | SFH | 2 | Manufacturer | accessdata.fda.gov |
| Software Algorithm Device To Assist Users In Digital Pathology | QPN | 2 | Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| May 4, 2026 | K254115 | ArteraAI Breast | SHW | Substantially Equivalent | Artera, Inc. | accessdata.fda.gov |
| July 31, 2025 | DEN240068 | ArteraAI Prostate | SFH | Unknown | Artera, Inc. | accessdata.fda.gov |
Updated May 4, 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.