FDA-cleared K183231
SIGNA Premier
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2019-01-18
Vendor
GE Medical Systems, LLC
19 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K183202
Deep Learning Image Reconstruction
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2019-04-12
FDA-cleared K183182
Critical Care Suite
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2019-08-12
FDA-cleared K201615
SIGNA 7.0T
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-10-15
FDA-cleared K201745
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-12-10
FDA-cleared K203617
MaxFOV 2
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2021-03-02
FDA-cleared K211118
SIGNA 7.0T
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2021-05-13
FDA-cleared K211846
Discovery MI Gen2
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2021-08-20
FDA-cleared K211161
Critical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2021-10-29
FDA-cleared K213999
Deep Learning Image Reconstruction
GE Medical Systems, LLC.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-02-18
FDA-cleared K223514
Spectral Bone Marrow
GE Medical Systems, LLC
Image analysis/processing for Bone using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Bone
- Decision
- 2023-03-09
FDA-cleared K230082
Auto Segmentation
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-05-04
FDA-cleared K223491
Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLC
Image analysis/processing for Chest/Lung using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Chest/Lung
- Decision
- 2023-05-25
FDA-cleared K241242
SIGNA MAGNUS
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2024-10-17
FDA-cleared K250379
SIGNA Prime Elite
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-03-17
FDA-cleared K243667
Sonic DL
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-06-05
FDA-cleared K250941
Revolution Vibe
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-08-01
FDA-cleared K251399
SIGNA Sprint
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-11
FDA-cleared K252379
AIR Recon DL
Ge Medical Systems, LLC
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-12-23