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510(k) Data Aggregation
K Number
K250901Device Name
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2025-07-22
(118 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K243398Device Name
CT Scanner TSX-501R/1 V11.1
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2025-06-20
(232 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is indicated to acquire and display cross-sectional volumes of the whole body (abdomen, pelvis, chest, extremities, and head) of adult patients.
TSX-501R has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
Device Description
CT Scanner TSX-501R/1 V11.1 employs a next-generation X-ray detector unit (photon counting detector unit), which allows images to be obtained based on X-rays with different energy levels. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
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K Number
K242808Device Name
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2025-05-13
(238 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.
Device Description
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V8.5 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.
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K Number
K250328Device Name
UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2025-04-30
(84 days)
Product Code
, IYN, IYO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UltraExtend NX CUW-U001S Ultrasound Image Analysis Program is designed to allow the user to observe images and perform analysis based on examination data acquired using the following diagnostic ultrasound systems; TUS-AI900, TUS-AI800, and TUS-AI700.
This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
Device Description
The UltraExtend NX, V2.0 is designed to allow the user to observe images and perform analysis based on examination data acquired using the Aplio i900/i800/i700 diagnostic ultrasound systems. RAW only or data saved in Image + RAW should be used for UltraExtend NX.
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K Number
K243335Device Name
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2025-01-07
(75 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces crosssectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Device Description
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K241496. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
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K Number
K242403Device Name
Aquilion ONE (TSX-308A/3) V1.5
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2024-12-23
(132 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion ONE has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AiCE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Network methods for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear applications.
The spectral imaging system allows the system to acquire two nearly simultaneous CT images of an anatomical location using distinct tube voltages and/or tube currents by rapid KV switching. The Xray dose will be the sum of the dose at each respective tube voltage and current in a rotation. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in X-ray attenuation between these distinct energies. When used by a qualified physician, a potential application is to determine the course of treatment.
PIQE* is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen and pelvis, and lung applications, in comparison to FBP and hybrid iterative reconstruction.
CLEAR Motion is a Deep Learning Reconstruction (DLR) method designed to reduce motion artifacts. A Deep Convolutional Network (DCNN) is used to estimate the patient's motion. This information is used in the reconstruction process to obtain lung images with less motion artifacts.
Device Description
Aquilion ONE (TSX-308A/3) V1.5 is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. This system is based upon the technology and materials of previously marketed Canon CT systems.
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K Number
K241582Device Name
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2024-09-12
(101 days)
Product Code
IYN, ITX, IYO, QIH
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound System Aplio i900 Model TUS-A1900, Aplio i800 Model TUS-A1800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler and Combination Dopler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.
Device Description
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V7.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.
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K Number
K233107Device Name
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2024-08-30
(338 days)
Product Code
OWB
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a digital radiography/fluoroscopy system used interventional angography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and lower extremities.
Device Description
The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5, is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm/ Ω-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
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K Number
K241496Device Name
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2024-08-20
(84 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vantage Galan 3T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.
MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are:
·Proton density (PD) (also called hydrogen density)
·Spin-lattice relaxation time (T1)
·Spin-spin relaxation time (T2)
·Flow dynamics
·Chemical Shift
Depending on the region of interest, contrast agents may be used. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.
Device Description
The Vantage Galan (Model MRT-3020) is a 3 Tesla Magnetic Resonance Imaging (MRI) System, previously cleared under K230355. This system is based upon the technology and materials of previously marketed Canon Medical Systems and is intended to acquire and display crosssectional transaxial, coronal, sagittal, and oblique images of anatomic structures of the head or body.
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K Number
K240705Device Name
Vitrea Software Package, VSTP-002A V2.0
Manufacturer
Canon Medical Systems Corporation
Date Cleared
2024-07-17
(125 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Canon Medical Systems Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea Software Package has the following additional indications:
Auto MPR Brain application is a post processing software of CT brain images that is intended to align images into a standard anatomical position for review. It provides tools to reformat images parallel to a standard anatomical position.
Subtraction Viewer is a viewer application that is intended for viewing original, subtraction and fusion CT images, but such subtraction processing is not a part of this application. This application supports fusion display of original image and subtraction image generated by other applications.
Device Description
The Vitrea Software Package, VSTP-002A V2.0, is a portfolio of applications software designed to be used in the Canon Medical Informatics Vitrea workstation. VSTP-002A currently includes post processing applications, Auto MPR Brain and Subtraction Viewer, which use CT image data, obtained from Canon CT Systems, to assist physicians in performing specialized measurements and analysis.
Auto MPR Brain is a software application that aligns CT brain images into a standard anatomical position for review.
Subtraction Viewer, also marketed as SCT Viewer, is a software application intended to view original, subtraction and fusion CT images. This application supports fusion display of original images and subtraction images generated by other applications and includes the ability to adjust fusion rate and ROI measurements of fusion images.
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