Modality
319 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Siemens Medical Solutions USA, Inc.
An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...
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.
GuideAI Health
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
Mighty Oak Medical
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
Fujifilm Corporation
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
Canon Medical Informatics, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Canon Medical Systems Corporation
Canon Aquilion ONE V2.0 acquires and processes whole-body CT volumes, including head, chest, abdomen, pelvis, cardiac, extremity, inner-ear, and multi-energy examinations with the...
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....
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Ever Fortune.Ai, Co., Ltd.
Triage notification of suspected appendicitis on contrast-enhanced abdominal CT
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...
JLK, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Philips Healthcare (Suzhou) Co., Ltd.
CT Rembra RT, CT Areta RT, and CT Rembra support whole-body diagnostic imaging, oncology, radiotherapy planning, interventional, vascular, neurological, cardiovascular, and...
Ge Healthcare Japan Corporation
True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
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...
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.
Voronoi Health Analytics Incorporated
DAFS automatically segments anatomy on DICOM Part 10 CT images and supports reviewed two- and three-dimensional visualization, editing, and area, volume, and intensity...
Canon Medical Systems Corporation
Aquilion Serve SP V2.0 acquires and displays cross-sectional whole-body CT volumes, with labeled AiCE, PIQE, and CLEAR Motion image-processing functions for supported examinations.
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.
Philips Medical Systems Nederland B.V.
AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac...
Harrison-AI Medical Pty, Ltd.
Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid...
Aidoc Medical, Ltd.
BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...
Median Technologies
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...
Precision Medical Ventures, Inc. Dba Revealdx
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...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 acquires cross-sectional whole-body CT images, including head, neck, cardiac, and vascular examinations, with labeled low-dose lung-cancer-screening use and uWS-CT-Dual...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
Coreline Soft Co.,Ltd
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
Mighty Oak Medical
Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory...
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.
Mlhealth 360
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
A2z Radiology Ai, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Mighty Oak Medical
Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...
ViTAA Medical Solutions, Inc.
AiORTA Plan analyzes cardiovascular CT angiography data to provide volumetric visualization and measurements as adjunctive information for licensed healthcare professionals; it is...
Circle Cardiovascular Imaging, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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....
Avatar Medical
brAIn Shoulder Positioning assists preoperative planning and visualization for primary total shoulder replacement by segmenting and measuring shoulder CT anatomy and supporting...
Spectrawave, Inc.
SpectraWAVE X1-FFR Software segments coronary vessels and reports vessel dimensions, stenosis quantification, and pressure-drop estimates under the supervision of a cardiologist.
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.
Thirona BV
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.
Disior Ltd
SMART PCFD uses algorithms to support orthopedic diagnosis and surgical planning for progressive collapsing foot deformity from weight-bearing CT, including three-dimensional...
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....
Qure.ai Technologies
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Careverse Technology Pte. Ltd.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Nurea
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images;...
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...
Brainomix Limited
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Methinks Software S.L.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
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.
iSchemaView
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Methinks Software S.L.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaview Inc.
Brain midline-shift measurement on adult non-contrast CT
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...
Infervision Medical Technology Co., Ltd.
Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
Shanghai United Imaging Healthcare Co.,Ltd.
uCT ATLAS Astound and uCT ATLAS are whole-body CT systems for head, body, cardiac, and vascular imaging, with dual-energy analysis options and protocol-governed low-dose...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
LARALAB GmbH
Cardiac CT segmentation, measurement and valve-intervention planning
Arineta Ltd.
SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and a...
Siemens Medical Solutions USA, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
BunkerHill Health
FDA product code KGI identifies this device class as Densitometer, Bone. Consult the linked FDA record for the exact authorized indications for use.
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....
TribusMed Beheer BV
TribusConnect provides remote viewing and manipulation of CT DICOM data for pre- and post-cardiac-intervention review, including volume rendering, heart segmentation, simulated...
V5med Inc.
V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or...
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....
Vent Creativity
Vent Creativity Knee v1.0 (Hermes) assists healthcare professionals in transferring CT imaging into bone segmentation and preoperative orthopedic planning outputs, including...
Avatar Medical
brAIn Shoulder Positioning assists shoulder surgeons with preoperative planning and visualization for primary total shoulder replacement by segmenting shoulder CT data and...
Coreline Soft Co., Ltd.
AVIEW assists physicians with quantitative CT analysis of thoracic and cardiac datasets, including lung, lobe, airway, fissure, nodule, coronary calcium, density, measurement, and...
Cleerly, Inc.
Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
JLK, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Shanghai United Imaging Healthcare Co., Ltd.
uCT 550 is a CT X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including...
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...
Imvaria, Inc
ScreenDx provides adjunctive positive/negative assessment of interstitial lung findings on DICOM lung CT in patients older than 22 years to support referral for clinical...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and...
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.
JLK, Inc.
Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT
Canon Medical Systems Corporation
Aquilion ONE (TSX-308A/3) V1.5 acquires and displays cross-sectional volumes of the whole body, including the head, with the capability to image whole organs in a single rotation....
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...
Aidoc Medical, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Intuitive Surgical Inc.
IRISeg receives DICOM-compliant contrast-enhanced CT images, provides manual and machine-learning-enabled image-analysis and segmentation tools, and creates an output file for a...
VinBrain Joint Stock Company
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ever Fortune.AI, Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Neurocareai Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
JLK, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Shanghai United Imaging Intelligence Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Avicenna.AI
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Shanghai United Imaging Intelligence Co., Ltd.
uAI Portal is a software solution for viewing, manipulating, communicating, and storing medical images and for supporting interpretation and evaluation in healthcare institutions....
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.
Hutom Inc.
RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional...
Mighty Oak Medical
Acorn Segmentation is intended as an image-segmentation interface for transferring CT or CTA images to an output file, measuring, and treatment planning. The output can be used to...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
SK Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Disior Ltd
SMART Bun-Yo-Matic CT analyzes CT images of the foot and ankle to provide three-dimensional visualizations, measurements, and surgical-planning information for orthopaedic care.
Circle Cardiovascular Imaging
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Avicenna.AI
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
Heuron Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Ever Fortune.AI, Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Canon Medical Systems Corporation
The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System acquires and displays cross-sectional volumes of the whole body, including the head, with whole-organ imaging in...
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...
Siemens Medical Solutions USA, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Healthcare GmbH
AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...
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...
Avicenna.AI
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
GE Hangwei Medical Systems Co., Ltd.
Revolution Ascend Sliding produces cross-sectional images by computer reconstruction of X-ray transmission data, including axial, cine, helical, cardiac, and gated acquisitions,...
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....
Thirona BV
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.
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.
Disior Ltd
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
Canon Medical Systems Corporation
The Aquilion Serve SP (TSX-307B/1) V1.3 acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using...
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.
Brainomix Limited
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
MeVis Medical Solutions AG
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 QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Arineta Ltd.
SpotLight and SpotLight Duo are dedicated cardiovascular and thoracic CT systems; K230370 adds optional deep-learning image reconstruction for patients older than 2 years to...
Neusoft Medical Systems Co., Ltd.
The NeuViz 128 Multi-Slice CT Scanner System is a whole-body computed-tomography X-ray system with a continuously rotating X-ray tube and detector array that reconstructs X-ray...
Ever Fortune.AI Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Brainomix Limited
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Annalise-AI Pty Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Annalise-AI Pty Ltd
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
TechsoMed
VisAble.IO is a CT image-processing software package for liver-ablation procedures that imports CT images from CT scanners and facility PACS, assists physicians in identifying...
Annalise-AI Pty Ltd
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Inc.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Brainomix Limited
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Healthcare GmbH
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
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.
MEDICALIP Co., Ltd
DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates...
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.
FEops nv
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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.
GE Healthcare Japan Corporation
Deep Learning Image Reconstruction is a deep-learning reconstruction method that produces cross-sectional images of the head and whole body from X-ray transmission data acquired...
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.
Annalise-AI Pty Ltd
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Viz. ai, Inc.
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
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 Aquilion Precision acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
iSchemaView, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Coreline Soft Co.,Ltd.
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uCT ATLAS Astound is a computed-tomography X-ray system that produces cross-sectional images of the whole body and is applicable to head, whole-body, cardiac, and vascular CT; it...
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....
Aidoc Medical, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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.
Coreline Soft Co.,Ltd.
AVIEW provides quantitative CT analysis of pulmonary and cardiac anatomy, including lung, lobe, airway, fissure, nodule, coronary calcium, and related measurements and reports to...
Philips Healthcare (Suzhou) Co., Ltd
The Philips CT 3500 produces CT images of the head and body and is indicated for head, whole-body, cardiac-calcium-scoring, and vascular CT in patients of all ages; it is also...
Aidoc Medical, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
AVICENNA.AI
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Viz.ai, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Canon Medical Systems Corporation
Aquilion Precision TSX-304A/4 V10.10 with AiCE is a CT system for cross-sectional imaging of the labeled abdomen, pelvis, chest, cardiac, extremity, and head examinations,...
iSchemaView Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Healthcare GmBh
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.
3D-Side SA
Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...
HeartLung Corporation
The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on the Discovery CT750 HD...
Viz.ai, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Medical Solutions USA, Inc.
syngo.CT Extended Functionality provides advanced visualization and processing tools for CT-acquired or reconstructed data, including labeled vessel, spectral, pulmonary,...
Elucid Bioimaging Inc.
ElucidVivo A.3 postprocesses contrast multidetector CT to visualize arterial vessels and provide semi-automatic lumen boundaries, stenosis and lumen measurements, vessel length,...
Canon Medical Systems Corporation
Aquilion ONE with Vitrea VSTP-001A provides whole-body CT acquisition and reconstruction with labeled FIRST, AiCE, spectral, cardiac, vascular, pulmonary, neurologic, abdominal,...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT provides head, whole-body, cardiac, and vascular CT imaging for patients of all ages and can support qualified low-dose lung screening under labeled programs...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
3D-Side SA
Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...
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 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 supports head, whole-body, cardiac, and vascular imaging on specified Revolution CT configurations with release-specific speed and...
GE Healthcare Japan Corporation
Revolution Ascend produces axial, cine, helical, cardiac, and gated CT images from X-ray transmission data with or without contrast, with post-processing and analysis for head,...
Siemens Medical Solutions USA, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Medical Solutions USA, Inc.
syngo.CT Extended Functionality provides advanced visualization and processing of CT-acquired or reconstructed data, with labeled trauma, spectral, vascular, pulmonary, oncology,...
Philips Medical Systems Nederland, B.V.
Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and...
AIbolit Technologies, LLC
AIBOLIT 3D+ processes, reviews, analyzes, communicates, and interchanges multidimensional digital images acquired from CT to support preoperative surgical planning, training,...
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.
Circle Neurovascular Imaging, Inc
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution Ascend.
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.
Canon Medical Systems Corporation
Aquilion Exceed LB is a CT system for cross-sectional imaging of the labeled body regions and examinations described in K211828, with professional review of acquired and...
Infervision Medical Technology Co., Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Nico.Lab B.V.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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...
Avicenna.AI
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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....
Aidoc Medical, Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Siemens Healthcare GmbH
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
Viz.ai, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Circle Cardiovascular Imaging Inc.
TruPlan provides CT image processing, visualization, measurements, and cardiac procedure-planning workflow support for the labeled use; exact procedure scope and outputs are...
Shanghai United Imaging Intelligence Co., Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
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...
Aidoc Medical, Ltd.
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
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...
NICo-Lab B.V.
HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...
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.
Coreline Soft Co., Ltd
AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung,...
Aidoc Medical, Ltd.
BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...
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.
MaxQ Al Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Shanghai United Imaging Healthcare Co., Ltd.
Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...
Beijing Infervision Technology Co.,Ltd.
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
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...
AVICENNA.AI
CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Qure.ai Technologies
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast standard- or low-dose cardiac CT, marks calcified coronary lesions, allocates them to the right coronary, left main, left anterior...
Zebra Medical Vision Ltd.
FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...
Coreline Soft Co., Ltd
AVIEW LCS reviews and analyzes thoracic CT images to characterize lung nodules in a single study or over time, including nodule measurements and release-specific Lung-RADS...
Nines, Inc.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
CuraCloud Corp.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
iSchemaView Incorporated
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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 QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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.
Siemens Medical Solutions, Inc
FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...
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.
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
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...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast cardiac CT, marks and allocates calcified coronary lesions to the right coronary, left main, left anterior descending, or circumflex...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution EVO.
Cleerly Inc
Cleerly Labs provides interactive cardiac CT or CCTA analysis for the presence and extent of coronary plaque, atherosclerosis, and stenosis in coronary artery disease or suspected...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Cardiovascular processes previously acquired CT DICOM studies to support quantitative and qualitative cardiovascular analysis, including heart segmentation and...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Pulmonary processes CT DICOM studies to support lung and lobe segmentation, measurements, density thresholds, and pulmonary-lesion segmentation, measurement, and...
Deep01 Limited
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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...
ClariPI Inc.
ClariCT.AI assists radiologists and specialists by denoising and enhancing DICOM CT images of the head, chest, heart, and abdomen, including low-dose filtered-back-projection and...
Zebra Medical Vision Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation. Volume...
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
Body Vision Medical 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.
Aidoc Medical, Ltd.
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
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 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.
Elucid Bioimaging Inc.
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
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.
MaxQ-Al Ltd.
Accipiolx prioritizes adult noncontrast head CT studies for cases with acute intracranial hemorrhage by sending studies from PACS to an analysis engine and returning case-level...
Aidoc Medical, Ltd.
BriefCase provides computer-assisted triage and notification for suspected intracranial hemorrhage on noncontrast head CT and or large-vessel occlusion on head CTA in parallel...
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.
Thirona 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.
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.
Viz.Al, Inc.
Triage/notification/prioritization
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.
ZEPMED, LLC.
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.
ALGOMEDICA
PixelShine is intended for networking, communication, processing, and enhancement of CT images in DICOM format to assist professional radiologists and specialists in reaching...
RIVERAIN TECHNOLOGIES, LLC
ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe...
IMBIO 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 SCS
Hepatic VCAR analyzes CT liver images to assess liver morphology and liver lesions with automated liver, lobe, segment, lesion, and measurement tools that a clinician can edit and...
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.