| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-06-24 | K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | Radiology |
| 2026-04-14 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | Ge Medical Systems, LLC | Radiology |
| 2026-03-20 | K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | Radiology |
| 2026-02-06 | K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | Radiology |
| 2026-02-05 | K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | Radiology |
| 2025-12-23 | K252379 | AIR Recon DL | Ge Medical Systems, LLC | Radiology |
| 2025-09-11 | K251399 | SIGNA™ Sprint | GE Medical Systems, LLC | Radiology |
| 2025-08-01 | K250941 | Revolution Vibe | GE Medical Systems, LLC | Radiology |
| 2025-06-05 | K243667 | Sonic DL | GE Medical Systems, LLC | Radiology |
| 2025-03-17 | K250379 | SIGNA Prime Elite | GE Medical Systems, LLC | Radiology |
| 2024-10-17 | K241242 | SIGNA MAGNUS | GE Medical Systems, LLC | Radiology |
| 2023-05-25 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite | GE Medical Systems, LLC | Radiology |
| 2023-05-04 | K230082 | Auto Segmentation | GE Medical Systems, LLC | Radiology |
| 2023-03-09 | K223514 | Spectral Bone Marrow | GE Medical Systems, LLC | Radiology |
| 2022-02-18 | K213999 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | Radiology |
| 2021-10-29 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm | GE Medical Systems, LLC | Radiology |
| 2021-08-20 | K211846 | Discovery MI Gen2 | GE Medical Systems, LLC. | Radiology |
| 2021-05-13 | K211118 | SIGNA 7.0T | GE Medical Systems, LLC | Radiology |
| 2021-03-02 | K203617 | MaxFOV 2 | GE Medical Systems, LLC. | Radiology |
| 2020-12-10 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | GE Medical Systems, LLC | Radiology |
| 2020-10-15 | K201615 | SIGNA 7.0T | GE Medical Systems, LLC | Radiology |
| 2019-08-12 | K183182 | Critical Care Suite | GE Medical Systems, LLC. | Radiology |
| 2019-04-12 | K183202 | Deep Learning Image Reconstruction | GE Medical Systems, LLC. | Radiology |
| 2019-01-18 | K183231 | SIGNA Premier | GE Medical Systems, LLC | Radiology |