Data / Medical devices / United States / Digital Diagnostics Inc.
Digital Diagnostics Inc.: FDA-registered device maker in Coralville, IA, United States, 3 510(k) clearances
Digital Diagnostics Inc. is registered with the FDA (registration 3014579028) in Coralville, IA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated June 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014579028
- Address
- 210 5th Street Suite 103, Coralville, IA, United States, 52241
- Owner or operator
- Digital Diagnostics Inc. (10058009)
- Roles
- Manufacturer
- First device listed
- June 25, 2018
- Registered through
- 2026
- Brand names listed
- IDx-DR, LumineticsCore
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diabetic Retinopathy Detection Device | PIB | 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 |
|---|---|---|---|---|---|---|
| June 17, 2022 | K213037 | IDx-DR v2.3 | PIB | Substantially Equivalent | Digital Diagnostics, Inc. | accessdata.fda.gov |
| June 10, 2021 | K203629 | IDx-DR | PIB | Substantially Equivalent | Digital Diagnostics, Inc. | accessdata.fda.gov |
| April 11, 2018 | DEN180001 | IDx-DR | PIB | Unknown | Idx, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 17, 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.