Use case
A buyer-oriented shortlist for ct/cta workflow. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Ge 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.
Subtle Medical, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Medical Systems Technologies, Ltd.
Spectral CT Verida Family supports the labeled spectral CT acquisition, reconstruction, material-map, and professional-interpretation workflow; exact models, protocols, and...
Siemens Medical Solutions USA, Inc.
SOMATOM X.cite and X.ceed with syngo CT VB20 support diagnostic CT, interventions, treatment preparation, radiation-therapy planning, and qualified low-dose lung screening.
BunkerHill Health
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.
BunkerHill Health
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.
Canon Medical Informatics, Inc.
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.
Imvaria, Inc.
Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support...
Terarecon,Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Bunkerhill Health
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.
iSchemaView, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Twinsight
SurgiTwin is a web pre-surgical knee-planning system that uses patient CT images to provide two-dimensional and three-dimensional planning information and a PDF report for adults...
BunkerHill Health
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Circle Cardiovascular Imaging Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
GE Medical Systems SCS
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.
Viz.ai, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
FUJIFILM Corporation
SCENARIA View acquires axial, helical, dynamic, and interventional CT images of the body, including the head and whole body, supports reformats and volume rendering, and includes...
Hi-D Imaging AG
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Artrya Limited
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Caristo Diagnostics Ltd.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Brainomix Limited
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Coreline Soft Co., Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
NAEOTOM Alpha.Peak, Alpha, Alpha.Pro, and Alpha.Prime with syngo CT VB20 generate and process cross-sectional CT images for trained staff as an aid in diagnosis, treatment,...
BunkerHill Health
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.
TeraRecon, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
iSchemaView, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Arineta Ltd.
SpotLight and SpotLight Duo produce cross-sectional cardiovascular and thoracic CT images, with the Low Dose Lung Cancer Screening Option for the labeled screening workflow, for...
Brainomix Limited
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Imbio, Inc.
FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...
Riverain Technologies, Inc.
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.
Aidoc Medical, Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
BunkerHill Health
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.
Imbio, Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Nano-X AI Ltd.
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.
Qure.ai Technologies
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 SCS
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.
Aidoc Medical, Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Philips Healthcare (Suzhou) Co., Ltd.
CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.
GE Healthcare Japan Corporation
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.
Genesis Software Innovations
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Coreline Soft Co., Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly...
Siemens Medical Solutions USA, Inc.
The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as...
Avicenna.AI
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
HighRAD Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Innolitics, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Nano-X AI Ltd.
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.
Viz.ai, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
iSchemaView, Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Imvaria, Inc
FDA product code QWO identifies this device class as Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Radiology software for referral of findings...
DASI Simulations
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
NICo-Lab B.V.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Aidoc Medical, Ltd.
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.
Aidoc Medical, Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Aidoc Medical, Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Imbio, Inc.
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.
Cedars-Sinai Medical Center: AIM
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Bunkerhill, Inc
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.
Yukun (Beijing) Technology Co., Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions U.S.A.
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.
Formus Labs, Ltd
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Brainomix Limited
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
iSchema View Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Circle Cardiovascular Imaging, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Viz.ai, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Medical Solutions USA, Inc.
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.
NanoxAI Ltd.
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.
ClariPi Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
GE Medical Systems SCS
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.
AIbolit Technologies, LLC
AIBOLIT 3D+ processes, reviews, analyzes, communicates, and interchanges multidimensional digital images acquired from CT to support preoperative surgical planning, training,...
Zebra Medical Vision Ltd.
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.
Shanghai United Imaging Healthcare Co., Ltd.
uCT ATLAS with uWS-CT-Dual Energy Analysis supports the labeled CT acquisition, reconstruction, and dual-energy image-analysis workflow for professional interpretation.
Qure.ai Technologies
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
ClariPi Inc.
ClariCT.AI receives, processes, and enhances supported CT DICOM images regardless of the labeled CT manufacturer or model for professional review within the cleared workflow.
Philips Healthcare (Suzhou) Co., Ltd.
Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by...
Genesis Software Innovations
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Imbio, LLC
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Optellum Ltd
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
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...
Nines, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
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.
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. Volume sets may be used for specialized studies by a trained and...
GE Healthcare Japan Corporation
Revolution Ascend is a diagnostic CT system for acquisition, reconstruction, display, and professional interpretation in the labeled scanner and protocol workflow.
GE Medical Systems SCS
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.
Coreline Soft Co., Ltd.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Cleerly, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
VIDA Diagnostics Inc.
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.
iSchemaView Inc.
FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...
Fluidda Inc.
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.
Icometrix NV
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Aquilion Prime SP with AiCE-i supports the labeled CT acquisition, reconstruction, visualization, and professional-interpretation workflow for the cleared scanner configuration.
GE Hangwei Medical Systems, Co., Ltd.
Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a...
Canon Medical Systems Corporation
Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis...
Vital Images, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Zebra Medical Vision Ltd.
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.
Viz.ai, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Arterys Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
RADLOGICS, INC.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.