Vendor
24 FDA-cleared listings in this directory.
Claim vendor profileGe Medical Systems, LLC
Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.
Ge Medical Systems, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ge Medical Systems, LLC
Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...
Ge Medical Systems, LLC
SIGNA Bolt is a whole-body MRI system for high-resolution diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol...
Ge Medical Systems, LLC
SIGNA Sprint Select is a whole-body MRI system for diagnostic imaging of the labeled body regions, with supported AI-assisted reconstruction, positioning, and protocol functions.
Ge Medical Systems, LLC
AIR Recon DL adds a deep-learning phase-correction and reconstruction option to supported GE 1.5T, 3T, and 7T MR workflows for all labeled anatomies and ages to reduce noise or...
GE Medical Systems, LLC
SIGNA Sprint is a 1.5T whole-body MRI system for diagnostic imaging of the labeled head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, vessels, and...
GE Medical Systems, LLC
Revolution Vibe is a general-purpose and cardiac-optimized CT system for head, whole-body, cardiac, and vascular imaging across the labeled age range.
GE Medical Systems, LLC
Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...
GE Medical Systems, LLC
SIGNA Prime Elite is a whole-body MR system that produces cross-sectional, spectroscopic, parametric, and dynamic images of the labeled body regions for trained physician...
GE Medical Systems, LLC
SIGNA MAGNUS is a head-only MR system intended for diagnostic imaging of structures and functions of the head, neck, temporomandibular joint, and limited cervical spine in...
GE Medical Systems, LLC
FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...
GE Medical Systems, LLC
Auto Segmentation generates initial DICOM RT Structure Set contours for 40 organs or subregions from adult contrast or noncontrast CT across head and neck, thorax, abdomen, and...
GE Medical Systems, LLC
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction supports head, whole-body, cardiac, and vascular imaging on specified Revolution CT configurations with release-specific speed and...
GE Medical Systems, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
GE Medical Systems, LLC.
Discovery MI Gen2 acquires and displays PET/CT images of radiopharmaceutical distribution and anatomical structures for qualified nuclear-medicine and radiology professionals...
GE Medical Systems, LLC
SIGNA 7.0T is a whole-body MR scanner for diagnostic and spectroscopic images, maps, spectra, and dynamic images of structures and functions of the head and extremities in...
GE Medical Systems, LLC.
MaxFOV 2 is a deep-learning CT image reconstruction method for head and whole-body axial, helical, and cine acquisitions. It extends the nominal display field of view when patient...
GE Medical Systems, LLC
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems, LLC
SIGNA 7.0T is a whole-body magnetic-resonance scanner indicated to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, spectra, and...
GE Medical Systems, LLC.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
GE Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction produces low, medium, or high-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution CT.
GE Medical Systems, LLC
SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K183231 adds AIRx, a deep-learning pre-scan feature that automates and...