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Digital Diagnostics Inc.

Country not established FDA establishment FEI 3014579028

Devices
4
Registrations
FDA
FDA recalls
0

Catalogue4

Newest first, rows 1-4 of 4

  • IDx-DR V2

    Class II
    None GUDID II
  • IDx-DR v2.3

    Class II
    None GUDID II
  • IDx-DR v2.3 Ref K213037

    Class II
    Active 510(k) 510(k) II
  • IDx-DR Ref K203629

    Class II
    Active 510(k) 510(k) II

Company details

FDA FEI number
3014579028
Address
210 5th Street, Coralville, IA, 52241

Frequently asked questions

How many devices does Digital Diagnostics Inc. have in the registry?

The registry currently lists 4 devices for Digital Diagnostics Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Digital Diagnostics Inc.'s devices?

Among its 4 most recently registered devices, Digital Diagnostics Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Digital Diagnostics Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Digital Diagnostics Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Digital Diagnostics Inc. in the registry?

The most recently registered devices listed for Digital Diagnostics Inc. include IDx-DR V2, IDx-DR v2.3 and IDx-DR.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.