Company profile

GE Medical Systems SCS

GE Medical Systems SCS has 13 AI-enabled medical devices on the FDA list. The first decision was on April 22, 2014 and the most recent on June 18, 2025 (CardIQ Suite). Its most common review panel is Radiology (13 devices).

13AI devices

2014First decision

2025Latest decision

1Specialties

Per year

20142019202020212022202320242025

GE Medical Systems SCS AI devices per year: 2014 1, 2019 1, 2020 3, 2021 1, 2022 1, 2023 2, 2024 1, 2025 3

By specialty

Radiology13

Related guides

Top radiology devices

Timeline

June 18, 2025 · 510(k) K243672CardIQ Suite · Radiology · JAK
April 21, 2025 · 510(k) K243651VersaViewer · Radiology · LLZ
February 25, 2025 · 510(k) K2434463DXR · Radiology · OWB
August 1, 2024 · 510(k) K233731CardIQ Suite · Radiology · JAK
July 13, 2023 · 510(k) K223424Spine Auto Views · Radiology · JAK
March 21, 2023 · 510(k) K223490FlightPlan for Embolization · Radiology · LLZ
March 11, 2022 · 510(k) K213725CardIQ Suite · Radiology · JAK
October 22, 2021 · 510(k) K210807FlightPlan for Liver · Radiology · LLZ
November 17, 2020 · 510(k) K193306PROView · Radiology · LLZ
November 12, 2020 · 510(k) K193289FastStroke, CT Perfusion 4D · Radiology · JAK
March 20, 2020 · 510(k) K193281Hepatic VCAR · Radiology · JAK
April 8, 2019 · 510(k) K183204Bone VCAR (BVCAR) · Radiology · JAK
April 22, 2014 · 510(k) K133649HEPATIC VCAR · Radiology · JAK