Company profile

Ge Medical Systems, LLC

Ge Medical Systems, LLC has 24 AI-enabled medical devices on the FDA list. The first decision was on January 18, 2019 and the most recent on June 24, 2026 (Enhanced Boundary for PCCT). Its most common review panel is Radiology (24 devices).

24AI devices

2019First decision

2026Latest decision

1Specialties

Per year

20192020202120222023202420252026

Ge Medical Systems, LLC AI devices per year: 2019 3, 2020 2, 2021 4, 2022 1, 2023 3, 2024 1, 2025 5, 2026 5

By specialty

Radiology24

Timeline

June 24, 2026 · 510(k) K253560Enhanced Boundary for PCCT · Radiology · JAK
April 14, 2026 · 510(k) K253502Critical Care Suite with Enteric Tube Positioning AI Algorithm · Radiology · QIH
March 20, 2026 · 510(k) K253520Photonova Spectra, Photonova Spectra Select · Radiology · JAK
February 6, 2026 · 510(k) K253780SIGNA Bolt · Radiology · LNH
February 5, 2026 · 510(k) K253779SIGNA Sprint Select · Radiology · LNH
December 23, 2025 · 510(k) K252379AIR Recon DL · Radiology · LNH
September 11, 2025 · 510(k) K251399SIGNA Sprint · Radiology · LNH
August 1, 2025 · 510(k) K250941Revolution Vibe · Radiology · JAK
June 5, 2025 · 510(k) K243667Sonic DL · Radiology · LNH
March 17, 2025 · 510(k) K250379SIGNA Prime Elite · Radiology · LNH
October 17, 2024 · 510(k) K241242SIGNA MAGNUS · Radiology · LNH
May 25, 2023 · 510(k) K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite · Radiology · QBS
May 4, 2023 · 510(k) K230082Auto Segmentation · Radiology · QKB
March 9, 2023 · 510(k) K223514Spectral Bone Marrow · Radiology · JAK
February 18, 2022 · 510(k) K213999Deep Learning Image Reconstruction · Radiology · JAK
October 29, 2021 · 510(k) K211161Critical Care Suite with Endotracheal Tube Positing AI algorithm · Radiology · QIH
August 20, 2021 · 510(k) K211846Discovery MI Gen2 · Radiology · KPS
May 13, 2021 · 510(k) K211118SIGNA 7.0T · Radiology · LNH
March 2, 2021 · 510(k) K203617MaxFOV 2 · Radiology · JAK
December 10, 2020 · 510(k) K201745Deep Learning Image Reconstruction for Gemstone Spectral Imaging · Radiology · JAK
October 15, 2020 · 510(k) K201615SIGNA 7.0T · Radiology · LNH
August 12, 2019 · 510(k) K183182Critical Care Suite · Radiology · QFM
April 12, 2019 · 510(k) K183202Deep Learning Image Reconstruction · Radiology · JAK
January 18, 2019 · 510(k) K183231SIGNA Premier · Radiology · LNH