Company profile

GE Healthcare

GE Healthcare has 8 AI-enabled medical devices on the FDA list. The first decision was on December 14, 2018 and the most recent on November 21, 2025 (Senographe Pristina 3D). Its most common review panel is Radiology (8 devices).

8AI devices

2018First decision

2025Latest decision

1Specialties

Per year

20182020202220232025

GE Healthcare AI devices per year: 2018 1, 2020 1, 2022 2, 2023 2, 2025 2

By specialty

Radiology8

Related guides

Top radiology devices

Timeline

November 21, 2025 · PMA P130020/S005Senographe Pristina 3D · Radiology · OTE
April 1, 2025 · 510(k) K242925MR Contour DL · Radiology · QKB
April 27, 2023 · 510(k) K223212Precision DL · Radiology · KPS
March 1, 2023 · 510(k) K221680Xeleris V Processing and Review System · Radiology · LLZ
February 17, 2022 · 510(k) K213689Voluson P6, Voluson P8 · Radiology · IYN
January 13, 2022 · 510(k) K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert · Radiology · IYN
September 25, 2020 · 510(k) K201103Xeleris V Processing and Review Systems · Radiology · LLZ
December 14, 2018 · 510(k) K182419Centricity Universal Viewer · Radiology · LLZ