No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B373VPS1090 | 1.0.9 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with toolsto aid them in reading, interpreting, reporting, and treatment planning. Visible Patient Suite accepts DICOMcompliant medical images acquired from a variety of imaging devices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.The software provides several categories of tools. It includes basic imaging tools for general images, including 2Dviewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion,surface rendering, measurements, reporting, storing, general image management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visiblein the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basicimage filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definitionthrough vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons and technicians) andis intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
2 | B373VPS10170 | 1.0.17 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi- Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition throughvascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
3 | B373VPS10150 | 1.0.15 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
4 | B373VPS10130 | 1.0.13 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
5 | B373VPS10120 | 1.0.12 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
6 | B373VPS10110 | 1.0.11 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite | |
7 | B373VPS10100 | 1.0.10 | Visible Patient Suite is medical imaging software that is intended to provide tr Visible Patient Suite is medical imaging software that is intended to provide trained medicalprofessionals with tools to aid them in reading, interpreting, reporting, and treatment planning.Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imagingdevices, including CT, MR.This product is not intended for use with or for the primary diagnostic interpretation ofMammography images.The software provides several categories of tools. It includes basic imaging tools for generalimages, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-PlanarReconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, generalimage management and administration tools, etc.It includes a basic image processing workflow and a custom UI to segment anatomical structures,which are visible in the image data (bones, organs, vascular/airway structures, etc.), includinginteractive segmentation tools, basic image filters, etc.It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), includingpath definition through vascular/airway, approximation of vascular/airway territories from tubularstructures and interactive labeling.The software is designed to be used by trained professionals (including physicians, surgeons andtechnicians) and is intended to assist the clinician who is solely responsible for making all finalpatient management decisions. | LLZ | System, Image Processing, Radiological | 2 | Visible Patient Suite |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04996005103128 | CCL650i2/AR | TOTOKU | JVC KENWOOD CORPORATION | ||
2 | 04996005103111 | CCL650i2/N | TOTOKU | JVC KENWOOD CORPORATION | ||
3 | 04996005103067 | MS25i2/F | TOTOKU | JVC KENWOOD CORPORATION | ||
4 | 04996005103050 | MS25i2/AR | TOTOKU | JVC KENWOOD CORPORATION | ||
5 | 04996005103043 | MS25i2/N | TOTOKU | JVC KENWOOD CORPORATION | ||
6 | 04996005103036 | MS35i2/F | TOTOKU | JVC KENWOOD CORPORATION | ||
7 | 04996005103029 | MS35i2/AR | TOTOKU | JVC KENWOOD CORPORATION | ||
8 | 04996005103012 | MS35i2/N | TOTOKU | JVC KENWOOD CORPORATION | ||
9 | 04996005102961 | CCL258i2/F | TOTOKU | JVC KENWOOD CORPORATION | ||
10 | 04996005102954 | CCL258i2/AR | TOTOKU | JVC KENWOOD CORPORATION | ||
11 | 04996005102947 | CCL258i2/N | TOTOKU | JVC KENWOOD CORPORATION | ||
12 | 04996005102930 | CCL358i2/F | TOTOKU | JVC KENWOOD CORPORATION | ||
13 | 04996005102923 | CCL358i2/AR | TOTOKU | JVC KENWOOD CORPORATION | ||
14 | 04996005102916 | CCL358i2/N | TOTOKU | JVC KENWOOD CORPORATION | ||
15 | 04995047061212 | GX240 | GX240-CL-BK-P | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
16 | 04995047061168 | GX240 | GX240-CL-BK | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
17 | 04995047061113 | GX340 | GX340-CL-BK-P | 3MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
18 | 04995047061069 | GX340 | GX340-CL-BK | 3MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
19 | 04995047049456 | MX215 | MX215-XBK | 2MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
20 | 04995047046202 | RX650 | RX650-ARBK | 6MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
21 | 04995047044178 | RX650 | RX650-BK | 6MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
22 | 04995047042419 | MX215 | MX215-BK | 2MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
23 | 04995047041788 | RX440 | RX440-BK | 4MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
24 | 04995047040255 | GX340 | GX340-CL-BK-P | 3MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
25 | 04995047040231 | GX340 | GX340-CL-BK | 3MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
26 | 04995047040217 | GX240 | GX240-CL-BK-P | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
27 | 04995047040194 | GX240 | GX240-CL-BK | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
28 | 04995047040170 | RX240 | RX240-BK | 2MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
29 | 04995047040002 | RX340 | RX340-ARBK | 3MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
30 | 04995047039983 | RX340 | RX340-BK | 3MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
31 | 04995047029021 | RS110 | RS110-BK | 1MP Color LCD Monitor | RadiForce® | EIZO CORPORATION |
32 | 04995047020561 | GS220 | GS220-CL-BK-P | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
33 | 04995047020554 | GS220 | GS220-CL-BK | 2MP Monochrome LCD Monitor | RadiForce® | EIZO CORPORATION |
34 | 04987670102493 | VSTP-001A | This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package.Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package. | Vitrea Software Toshiba Package | CANON MEDICAL SYSTEMS CORPORATION | |
35 | 04987670102370 | USWP-100A | 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE | 4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE | CANON MEDICAL SYSTEMS CORPORATION | |
36 | 04987670101014 | USWS-900A | ULTRASOUND WORKSTATION PACKAGE | ULTRASOUND WORKSTATION PACKAGE | CANON MEDICAL SYSTEMS CORPORATION | |
37 | 04987670100796 | TUW-U001S | ULTRASOUND WORKSTATION PACKAGE | ULTRASOUND WORKSTATION PACKAGE | CANON MEDICAL SYSTEMS CORPORATION | |
38 | 04897117800007 | AccuBrain_Intl | AccuBrain | BRAINNOW MEDICAL TECHNOLOGY LIMITED | ||
39 | 04779049590105 | 7.5.1 | NA | MedDream is a software medical imaging system used to receive DICOM images, sche MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians.Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data. | MedDream | SOFTNETA UAB |
40 | 04719875623103 | 1.0 | UO-0102 | AmCAD UO is a PC based, self contained, non invasive image analysis software app AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state. | AmCAD UO | AMCAD BIOMED CORPORATION |
41 | 04719875621130 | 2.2 | UT-0222-1Q | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
42 | 04719875621123 | 2.2 | UT-0222-1P | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
43 | 04719875621116 | 2.2 | UT-0222-KOL | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
44 | 04719875621109 | 2.2 | UT-0222-50 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
45 | 04719875621093 | 2.2 | UT-0222-1000 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
46 | 04719875621086 | 2.2 | UT-0222-1Y | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
47 | 04719875621024 | 2.2 | UT-0222-500 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
48 | 04719875621017 | 2.2 | UT-0222-D | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
49 | 04719875621000 | 2.2 | UT-0222 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
50 | 04573596213759 | DAS-RS1 | ULTRASOUND DATA ANALYSIS SYSTEM | DAS-RS1 | FUJIFILM HEALTHCARE CORPORATION |