Vendor
42 FDA-cleared listings in this directory.
Claim vendor profileCanon 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...
Canon Medical Systems Corporation
Vantage Fortian and Orian 1.5T produce diagnostic MR images of the head and body, including labeled noncontrast angiography, for trained technologists and physician interpretation.
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.
Canon Medical Systems Corporation
Alphenix and INFX-8000V/B,S V9.6 with aEvolve FOV Extension are digital radiography and fluoroscopy systems for diagnostic and interventional angiography, with labeled real-time...
Canon Medical Systems Corporation
Cartesion Prime PET/CT acquires cross-sectional CT images and PET radiopharmaceutical-distribution images and includes AiCE-i PET processing and a neural-network...
Canon Medical Systems Corporation
Aplio i900, i800, and i700 software V9.0 are mobile multi-region diagnostic ultrasound systems for physicians and appropriately trained healthcare professionals; the submission...
Canon Medical Systems Corporation
Alphenix V9.6 with aEvolve Imaging is a digital radiography and fluoroscopy system for diagnostic and interventional angiography of the labeled vessels, with AI Denoising and MFP...
Canon Medical Systems Corporation
Canon Vantage Fortian and Orian 1.5T MR systems acquire and display diagnostic MR images of the labeled head and body, including the described noncontrast MR angiography workflow.
Canon Medical Systems Corporation
UltraExtend NX allows a user to observe images and perform analysis based on examination data from the named diagnostic ultrasound systems in hospital and clinical settings by...
Canon Medical Systems Corporation
Vantage Galan 3T is a head and body diagnostic MRI system with noncontrast MRA and AiCE deep-learning reconstruction; K243335 also covers the PIQE image-processing workflow under...
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....
Canon Medical Systems Corporation
Aplio i900/i800/i700 V7.0 is a mobile diagnostic ultrasound system with supported body and cardiac clinical applications and imaging modes for trained physicians and legally...
Canon Medical Systems Corporation
The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a magnetic-resonance diagnostic device for producing cross-sectional MR images and related...
Canon Medical Systems Corporation
The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR is a magnetic-resonance diagnostic device for producing cross-sectional MR images...
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...
Canon Medical Systems Corporation
Aplio i900, i800, and i700 software V8.1 are mobile diagnostic ultrasound systems for trained physicians or legally qualified users across multi-region diagnostic applications; on...
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...
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...
Canon Medical Systems Corporation
Cartesion Prime is a PET/CT system for acquisition, reconstruction, fusion, visualization, and professional interpretation within the cleared configuration and radiopharmaceutical...
Canon Medical Systems Corporation
FDA product code JAA identifies this device class as System, X-Ray, Fluoroscopic, Image-Intensified. Consult the linked FDA record for the exact authorized indications for use.
Canon Medical Systems Corporation
Vantage Galan 3T with MRT-3020 and V9.0 with AiCE Reconstruction Processing Unit acquires and reconstructs labeled diagnostic MR examinations on the compatible scanner...
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...
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,...
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,...
Canon Medical Systems Corporation
Vantage Galan 3T with MRT-3020 V8.0 and the AiCE Reconstruction Processing Unit for MR produces cross-sectional and spectroscopic MR images and physical parameters of the head,...
Canon Medical Systems Corporation
Aplio a550, Aplio a450, and Aplio a software V6.5 are mobile diagnostic ultrasound systems for trained physicians or legally qualified users to visualize structures and dynamic...
Canon Medical Systems Corporation
Aplio i900/i800/i700 software V6.5 is a mobile diagnostic ultrasound system for trained physicians or legally qualified users to visualize structures and dynamic processes and...
Canon Medical Systems Corporation
Vantage Fortian 1.5T with MRT-1550 V8.0 and the AiCE Reconstruction Processing Unit for MR produces diagnostic MR images and physical parameters of the head, body, and extremities...
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...
Canon Medical Systems Corporation
Cartesion Prime is a PET/CT system for acquisition, reconstruction, fusion, visualization, and professional interpretation within the cleared configuration and radiopharmaceutical...
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...
Canon Medical Systems Corporation
Vantage Galan 3T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
Canon Medical Systems Corporation
Vantage Orian 1.5T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
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...
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...
Canon Medical Systems Corporation
Vantage Orian 1.5T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can perform...
Canon Medical Systems Corporation
Vantage Galan 3T systems are indicated as a diagnostic imaging modality producing transaxial, coronal, sagittal, and oblique images of the head or body. The system can also...
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...
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...
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...