Company profile

GE Medical Systems Ultrasound and Primary Care Diagnostics

GE Medical Systems Ultrasound and Primary Care Diagnostics has 31 AI-enabled medical devices on the FDA list. The first decision was on May 2, 2018 and the most recent on March 24, 2026 (LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power). Its most common review panel is Radiology (31 devices).

31AI devices

2018First decision

2026Latest decision

1Specialties

Per year

20182020202120222023202420252026

GE Medical Systems Ultrasound and Primary Care Diagnostics AI devices per year: 2018 2, 2020 3, 2021 1, 2022 6, 2023 3, 2024 3, 2025 10, 2026 3

By specialty

Radiology31

Timeline

March 24, 2026 · 510(k) K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power · Radiology · IYN
January 8, 2026 · 510(k) K253370LOGIQ Totus · Radiology · IYN
January 7, 2026 · 510(k) K253366LOGIQ Fortis · Radiology · IYN
November 24, 2025 · 510(k) K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 · Radiology · IYN
October 29, 2025 · 510(k) K251985LOGIQ E10 · Radiology · IYN
October 29, 2025 · 510(k) K251963LOGIQ E10s · Radiology · IYN
July 25, 2025 · 510(k) K251322Venue; Venue Go; Venue Fit; Venue Sprint · Radiology · IYN
July 16, 2025 · 510(k) K251342EchoPAC Software Only / EchoPAC Plug-in · Radiology · QIH
July 10, 2025 · 510(k) K251169Vivid Pioneer · Radiology · IYN
May 29, 2025 · 510(k) K250543Voluson Performance 16; Voluson Performance 18 · Radiology · IYN
May 1, 2025 · 510(k) K250087Vscan Air · Radiology · IYN
February 11, 2025 · 510(k) K243628Vivid T9/Vivid T8 · Radiology · IYN
February 11, 2025 · 510(k) K243620Vivid iq · Radiology · IYN
December 20, 2024 · 510(k) K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 · Radiology · IYN
October 2, 2024 · 510(k) K242005Versana Premier; Versana Premier Lotus; LOGIQ F · Radiology · IYN
March 7, 2024 · 510(k) K233692Voluson Signature 20, Voluson Signature 18 · Radiology · IYN
December 7, 2023 · 510(k) K232381LOGIQ Totus · Radiology · IYN
November 7, 2023 · 510(k) K231966LOGIQ E10 · Radiology · IYN
October 30, 2023 · 510(k) K231965Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 · Radiology · IYN
July 22, 2022 · 510(k) K220940EchoPAC Software Only, EchoPAC Plug-in · Radiology · QIH
July 18, 2022 · 510(k) K221147Vivid T8, Vivid T9 · Radiology · IYN
July 15, 2022 · 510(k) K220619Vivid S60N, Vivid S70N · Radiology · IYN
June 21, 2022 · 510(k) K220800Venue Go · Radiology · IYN
June 6, 2022 · 510(k) K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 · Radiology · IYN
May 11, 2022 · 510(k) K220446Versana Balance · Radiology · IYN
September 10, 2021 · 510(k) K210438Versana Premier · Radiology · IYN
September 18, 2020 · 510(k) K200852EchoPAC Software Only, EchoPAC Plug-In · Radiology · LLZ
September 9, 2020 · 510(k) K200851Vivid T8, Vivid T9 · Radiology · IYN
July 16, 2020 · 510(k) K200497Vivid S60N, Vivid S70N · Radiology · IYN
October 25, 2018 · 510(k) K181685Vivid E80, Vivid E90, Vivid E95 · Radiology · IYN
May 2, 2018 · 510(k) K180599Venue · Radiology · IYN