Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE. FDA records under 11 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list GE Medical Systems with 332 510(k) clearances, 168 device recalls and 28 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 13, 2026: AIR Recon DL.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 13, 2026 | AIR Recon DLK253808 · LNH | 510(k) clearances |
| Jun 24, 2026 | Enhanced Boundary for PCCTK253560 · JAK | 510(k) clearances |
| Jun 24, 2026 | Enhanced Boundary for PCCTK253560 · Radiology | AI-enabled devices |
| Jun 5, 2026 | Optima XR200amx, Mobile Digital-Ready Radiographic SystemClass II · GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement comple | Device recalls |
| Jun 5, 2026 | Optima XR220amx, Mobile Digital-Ready Radiographic SystemClass II · GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement comple | Device recalls |
| Jun 5, 2026 | Optima XR240amx, Mobile Digital Radiographic SystemClass II · GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement comple | Device recalls |
| May 1, 2026 | Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500Class II · GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the dev | Device recalls |
| May 1, 2026 | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsClass II · GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the dev | Device recalls |
| May 1, 2026 | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2Class II · GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the dev | Device recalls |
| Apr 20, 2026 | Allia IGS 3 Pulse angiographic X-ray systemClass II · GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with G | Device recalls |
| Apr 20, 2026 | Allia IGS Pulse angiographic X-ray systemClass II · GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with G | Device recalls |
| Apr 14, 2026 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253502 · QIH | 510(k) clearances |
| Apr 14, 2026 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmK253502 · Radiology | AI-enabled devices |
| Mar 20, 2026 | Photonova Spectra, Photonova Spectra SelectK253520 · JAK | 510(k) clearances |
| Mar 20, 2026 | Photonova Spectra, Photonova Spectra SelectK253520 · Radiology | AI-enabled devices |
| Feb 6, 2026 | SIGNA™ BoltK253780 · LNH | 510(k) clearances |
| Feb 6, 2026 | SIGNA BoltK253780 · Radiology | AI-enabled devices |
| Feb 5, 2026 | SIGNA™ Sprint SelectK253779 · LNH | 510(k) clearances |
| Feb 5, 2026 | SIGNA Sprint SelectK253779 · Radiology | AI-enabled devices |
| Dec 23, 2025 | AIR Recon DLK252379 · LNH | 510(k) clearances |
| Dec 23, 2025 | AIR Recon DLK252379 · Radiology | AI-enabled devices |
| Sep 11, 2025 | SIGNA™ SprintK251399 · LNH | 510(k) clearances |
| Sep 11, 2025 | SIGNA SprintK251399 · Radiology | AI-enabled devices |
| Aug 1, 2025 | Revolution VibeK250941 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
