Data / Medical devices / United States / Fundus Photo
Fundus Photo: FDA-registered device maker in Saint Louis, MO, United States, 1 510(k) clearance
Fundus Photo is registered with the FDA (registration 3007237389) in Saint Louis, MO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007237389
- Address
- 1240 Dielman Industrial Court, Saint Louis, MO, United States, 63132
- Owner or operator
- Fundus Photo (10027139)
- Roles
- Manufacturer
- First device listed
- March 28, 2025
- Registered through
- 2026
- Brand names listed
- Fundus Photo Ophthalmic Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 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 17, 2010 | K093071 | FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 | HKI | Substantially Equivalent | Fundus Photo, LLC | accessdata.fda.gov |
Compare with other makers
Updated November 17, 2010. 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.