Digital Diagnostics, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
IDx-DR v2.3510(k)Jun 17, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jun 17, 2022
IDx-DR510(k)Jun 10, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jun 10, 2021