Data / Medical devices / United States / Avenda Health Inc.
Avenda Health Inc.: FDA-registered device maker in Culver City, CA, United States, 1 510(k) clearance
Avenda Health Inc. is registered with the FDA (registration 3022983474) in Culver City, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3022983474
- Address
- 4130 Overland Ave, Culver City, CA, United States, 90230
- Owner or operator
- Avenda Health Inc. (10086689)
- Roles
- Manufacturer
- First device listed
- December 2, 2022
- Registered through
- 2026
- Brand names listed
- Unfold AI
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 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 |
|---|---|---|---|---|---|---|
| November 22, 2022 | K221624 | Avenda Health AI Prostate Cancer Planning Software | POK | Substantially Equivalent | Avenda Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 2022. 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.