Company profile

Arterys, Inc.

Arterys, Inc. has 6 AI-enabled medical devices on the FDA list. The first decision was on January 5, 2017 and the most recent on September 3, 2025 (Tempus Pixel). Its most common review panel is Radiology (6 devices).

6AI devices

2017First decision

2025Latest decision

1Specialties

Per year

20172018202020222025

Arterys, Inc. AI devices per year: 2017 1, 2018 2, 2020 1, 2022 1, 2025 1

By specialty

Radiology6

Related guides

Top radiology devices

Timeline

September 3, 2025 · 510(k) K252539Tempus Pixel · Radiology · QIH
March 14, 2022 · 510(k) K203744Arterys MICA · Radiology · QIH
March 25, 2020 · 510(k) K192437Arterys MICA · Radiology · QIH
October 17, 2018 · 510(k) K182034Arterys MICA · Radiology · LLZ
January 25, 2018 · 510(k) K173542Arterys Oncology DL · Radiology · LLZ
January 5, 2017 · 510(k) K163253Arterys Cardio DL · Radiology · LLZ