Company profile

Digital Diagnostics Inc.

Digital Diagnostics Inc. has 2 AI-enabled medical devices on the FDA list. The first decision was on June 10, 2021 and the most recent on June 17, 2022 (IDx-DR v2.3). Its most common review panel is Ophthalmic (2 devices).

2AI devices

2021First decision

2022Latest decision

1Specialties

Timeline

June 17, 2022 · 510(k) K213037IDx-DR v2.3 · Ophthalmic · PIB
June 10, 2021 · 510(k) K203629IDx-DR · Ophthalmic · PIB