Company profile

Healthy.io Ltd.

Healthy.io Ltd. has 4 AI-enabled medical devices on the FDA list. The first decision was on July 18, 2018 and the most recent on September 8, 2023 (Minuteful-kidney test). Its most common review panel is Clinical Chemistry (4 devices).

4AI devices

2018First decision

2023Latest decision

1Specialties

Per year

2018201920222023

Healthy.io Ltd. AI devices per year: 2018 1, 2019 1, 2022 1, 2023 1

By specialty

Clinical Chemistry4

Timeline

September 8, 2023 · 510(k) K222921Minuteful-kidney test · Clinical Chemistry · JIR
July 6, 2022 · 510(k) K210069Minuteful - kidney test · Clinical Chemistry · JIR
July 26, 2019 · 510(k) K182384ACR LAB Urine Analysis Test System · Clinical Chemistry · JFY
July 18, 2018 · 510(k) K173327DIP/U.S. Urine Analysis Test System · Clinical Chemistry · JIL