GE Medical Systems, LLC
13 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| September 11, 2025 | K251399 | SIGNA Sprint | Radiology | LNH |
| August 1, 2025 | K250941 | Revolution Vibe | Radiology | JAK |
| June 5, 2025 | K243667 | Sonic DL | Radiology | LNH |
| March 17, 2025 | K250379 | SIGNA Prime Elite | Radiology | LNH |
| October 17, 2024 | K241242 | SIGNA MAGNUS | Radiology | LNH |
| May 25, 2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | Radiology | QBS |
| May 4, 2023 | K230082 | Auto Segmentation | Radiology | QKB |
| March 9, 2023 | K223514 | Spectral Bone Marrow | Radiology | JAK |
| October 29, 2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | Radiology | QIH |
| May 13, 2021 | K211118 | SIGNA 7.0T | Radiology | LNH |
| December 10, 2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | Radiology | JAK |
| October 15, 2020 | K201615 | SIGNA 7.0T | Radiology | LNH |
| January 18, 2019 | K183231 | SIGNA Premier | Radiology | LNH |