No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10841962113998 | RT-1804 | RT-1804 | Aquaplast RT Sheet, 24" x 36", 3.2mm, Solid, XS | IYE | Accelerator, linear, medical | 2 | Aquaplast RT™ |
2 | 10841962105740 | RT-1889KSD-S3 | RT-1889KSD-S3 | Fibreplast Splt Hd Only S-Frame Gap, 3.2mm | IYE | Accelerator, linear, medical | 2 | Fibreplast™ |
3 | 10841962102428 | RT-1782S | RT-1782S | Aquaplast RT Reloadable Hd+Shldr S-Frame, 2.4mm | IYE | Accelerator, linear, medical | Aquaplast RT™ | |
4 | 10841962119198 | RT-4517-7070F20 | RT-4517-7070F20 | VacQfix Cushion, 70cm x 70cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
5 | 10841962119358 | RT-4517-T7993F20M | RT-4517-T7993F20M | VacQfix Cushion 79cm x 93cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
6 | 10841962119341 | RT-4517-T7993F20 | RT-4517-T7993F20 | VacQfix Cushion 79cm x 93cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
7 | 10841962119334 | RT-4517-T6565F7M | RT-4517-T6565F7M | VacQfix Cushion, 65cm x 65cm, T-Shaped, 7L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
8 | 10841962119327 | RT-4517-T6565F7 | RT-4517-T6565F7 | VacQfix Cushion, 65cm x 65cm, T-Shaped , 7L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
9 | 10841962119310 | RT-4517-PB4M | RT-4517-PB4M | VacQfix Cushion, 96 X 55cm, 15L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
10 | 10841962119303 | RT-4517-PB4 | RT-4517-PB4 | VacQfix Cushion, 96 x 55 cm, 15L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
11 | 10841962119297 | RT-4517-PB3M | RT-4517-PB3M | VacQfix Cushion, 96 X 55cm, 12L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
12 | 10841962119280 | RT-4517-PB3 | RT-4517-PB3 | VacQfix Cushion, 96 x 55 cm, 12L Fill | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
13 | 10841962119273 | RT-4517-PB2M | RT-4517-PB2M | VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
14 | 10841962119266 | RT-4517-PB2 | RT-4517-PB2 | VacQfix Cushion, Prone Breast Cushion Without Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
15 | 10841962119259 | RT-4517-PB1M | RT-4517-PB1M | VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
16 | 10841962119242 | RT-4517-PB1 | RT-4517-PB1 | VacQfix Cushion, Prone Breast Cushion w/Contralateral Breast Support | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
17 | 10841962119235 | RT-4517-IND01 | RT-4517-IND01 | VacQFix Indexer | JAI | Couch, Radiation Therapy, Powered | 2 | VacQfix™ |
18 | 10841962119228 | RT-4517-80150F65M | RT-4517-80150F65M | VacQfix Cushion, 150cm x 80cm, 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
19 | 10841962119211 | RT-4517-80150F65 | RT-4517-80150F65 | VacQfix Cushion, 150cm x 80cm, 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
20 | 10841962119204 | RT-4517-7070F20M | RT-4517-7070F20M | VacQfix Cushion, 70cm x 70cm, 20L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
21 | 10841962119181 | RT-4517-70230F65FM | RT-4517-70230F65FM | Vac Q-Fix Cushion 70 x 230 , 65L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
22 | 10841962119174 | RT-4517-70230F65F | RT-4517-70230F65F | VacQfix Cushion 70 x 230 , 65L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
23 | 10841962119167 | RT-4517-70150F60M | RT-4517-70150F60M | VacQfix Cushion 70cm x 150cm 60L | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
24 | 10841962119150 | RT-4517-70150F60 | RT-4517-70150F60 | VacQfix Cushion, 70cm x 150cm, 60L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
25 | 10841962119143 | RT-4517-70120F40M | RT-4517-70120F40M | Vac-Q-Fix Cushion, 120xm x 70cm, 40L Fill Gen.II (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
26 | 10841962119136 | RT-4517-70120F40 | RT-4517-70120F40 | VacQfix Cushion, 120xm x 70cm, 40L Fill Gen.II | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
27 | 10841962119129 | RT-4517-5070F15M | RT-4517-5070F15M | VacQfix Cushion, 50cm x 70cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
28 | 10841962119112 | RT-4517-5070F15 | RT-4517-5070F15 | VacQfix Cushion, 50cm x 70cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
29 | 10841962119105 | RT-4517-4080F15M | RT-4517-4080F15M | VacQfix Cushion, 40cm x 80cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
30 | 10841962119099 | RT-4517-4080F15 | RT-4517-4080F15 | VacQfix Cushion, 40cm x 80cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
31 | 10841962119082 | RT-4517-4079VF15M | RT-4517-4079VF15M | VacQfix Cushion 40cm x 80cm, 15L Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
32 | 10841962119075 | RT-4517-4079VF15 | RT-4517-4079VF15 | VacQfix Cushion, 40cm x 79cm, 15L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
33 | 10841962119068 | RT-4517-2535F2.0M | RT-4517-2535F2.0M | Vac-Q-Fix Cushion, 25cm x 35cm, 2.0L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
34 | 10841962119051 | RT-4517-2535F2.0 | RT-4517-2535F2.0 | VacQfix Cushion, 25cm x 35cm, 2.0L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
35 | 10841962119044 | RT-4517-2535F1.5M | RT-4517-2535F1.5M | Vac-Q-Fix Cushion, 25cm x 35cm, 1.5L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
36 | 10841962119037 | RT-4517-2535F1.5 | RT-4517-2535F1.5 | VacQfix Cushion, 25cm x 35cm, 1.5L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
37 | 10841962119020 | RT-4517-230120T80F90M | RT-4517-230120T80F90M | VacQfix Cushion, 120/20cm x 230cm,90L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
38 | 10841962119013 | RT-4517-230120T80F90 | RT-4517-230120T80F90 | VacQfix Cushion, 120/80cm x 230cm, 90L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
39 | 10841962119006 | RT-4517-12075F35M | RT-4517-12075F35M | Vac-Q-Fix Cushion 120cm x 75cm, 35L Fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
40 | 10841962118993 | RT-4517-12075F35 | RT-4517-12075F35 | VacQfix Cushion 120cm x 75cm, 35L Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
41 | 10841962118986 | RT-4517-10070F43M | RT-4517-10070F43M | Vac-Q-Fix Cushion, 100cm x 70cm, 43L fill (Economy valve) | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
42 | 10841962118979 | RT-4517-10070F43 | RT-4517-10070F43 | VacQfix Cushion, 100cm x 70cm, 43L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
43 | 10841962118962 | RT-4517-10070F40M | RT-4517-10070F40M | VacQfix Cushion, 100cm x 70cm, 40L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
44 | 10841962118955 | RT-4517-10070F40 | RT-4517-10070F40 | VacQfix Cushion, 100cm x 70cm, 40L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
45 | 10841962118948 | RT-4517-10070F35M | RT-4517-10070F35M | VacQfix Cushion, 100cm x70cm, 35 liter Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
46 | 10841962118931 | RT-4517-10070F35 | RT-4517-10070F35 | VacQfix Cushion, 100 cm x 70 cm 35 liter Fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
47 | 10841962118924 | RT-4517-10070F30M | RT-4517-10070F30M | VacQfix Cushion, 100cm x 70cm, 30L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
48 | 10841962118917 | RT-4517-10070F30 | RT-4517-10070F30 | VacQfix Cushion, 100cm x 70cm, 30L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
49 | 10841962118900 | RT-4517-100220F120M | RT-4517-100220F120M | VacQfix Cushion, 100cm x 220cm, 120L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
50 | 10841962118894 | RT-4517-100220F120 | RT-4517-100220F120 | VacQfix Cushion, 100cm x 220cm, 120L fill | JAI | Couch, radiation therapy, powered | 2 | VacQfix™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B554MRCP1000 | 1.0 | MRCP+v1 is indicated for use as a software-based image processing system for non MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation, visualisation and review of three-dimensional quantitative biliary system models and anatomical image data.MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.Combining image viewing, processing and reporting tools, the metrics provided is designed to support physicians in the visualization, evaluation and reporting of hepatobiliary structures. These models and the physical parameters derived from the models, when interpreted by a trained physician, yield information that may assist in biliary system assessment.MRCP+v1 is designed to utilize DICOM compliant MRCP datasets, acquired on supported MR scanners using supported MRCP acquisition protocols.MRCP+v1 is suitable for all patients not contra-indicated for MRI. | MRCP+ | PERSPECTUM LTD | |
2 | B554LMS5000 | 5.0.0 | LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnosti LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LMSv5 is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LMSv5 provides several tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
3 | B554LMS4000 | 4.0.0 | LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv4) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv4) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv4) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may optionally be computed using the DIXON or LMS MOST methodologies. These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
4 | B554LMS3500 | 3.5.0 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
5 | B554LMS3400 | 3.4.0 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
6 | B554LMS3300 | 3.3.0 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
7 | B554LMS3200 | 3.2.0 | LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic d LiverMultiScan (LMSv3) is indicated for use as a magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times. LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced. LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions includes the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis. | LiverMultiScan | PERSPECTUM LTD | |
8 | B554LMS3100 | 3.1.0 | LiverMultiScan (LMSv3) is a standalone software device. The purpose of the Liver LiverMultiScan (LMSv3) is a standalone software device. The purpose of the LiverMultiScan (LMSv3) device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). The LiverMultiScan (LMSv3) is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is then sent to an interpreting clinician.The interpreting clinician needs to take into consideration the device’s limitations and accuracy during clinical interpretation.LiverMultiScan (LMSv3) is not intended to replace the established procedures for the assessment of a patients liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.The device is intended to be used by a trained operator to generate metrics for subsequent interpretation by a clinician.The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan (LMSv3) metrics. The purpose of a LiverMultiScan (LMSv3) metrics is to provide imaging information to assist in characterizing tissue in the liver, which are additional to existing methods for obtaining information relating to the liver. LiverMultiScan (LMSv3) metrics are not intended to replace any existing diagnostic source of information, but can be used to identify patients who | LiverMultiScan | PERSPECTUM LTD | |
9 | B554LMS2100 | 2.1 | LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. | LiverMultiScan | PERSPECTUM LTD | |
10 | B554LMS2000 | 2.0 | LiverMultiScan is a standalone software device. The purpose of the LiverMultiSca LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease.Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision. | LiverMultiScan | PERSPECTUM LTD | |
11 | B554HEPATICA100 | 1.0.0 | Hepatica (Hepatica v1) is a post-processing medical device software that present Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient’s liver health.Hepatica (Hepatica v1) uses image visualisation and analysis tools to process DICOM 3.0 compliant magnetic resonance image datasets to produce semi-automatic segmented 3D models of the liver based on the work of Couinaud and the Brisbane 2000 terminology. For each identified Couinaud segment, volumetric data is determined and reported. Hepatica (Hepatica v1) may also report iron corrected-T1 (cT1) and PDFF calculated using the IDEAL methodfrom multi-slice acquisitions, on a per segment basis, over the whole liver. Both metrics present numerical values of different fundamental liver tissue characteristics that can be used as measures of liver tissue health.Hepatica (Hepatica v1) provides trained clinicians with additional information to evaluate the volume and health of a patient’s liver on a segmental basis. It is not intended to replace the established procedures for the assessment of a patient’s liver health. However, information gathered through existing diagnostic tests, clinical evaluation of the patient, as well Hepatica(Hepatica v1), may support surgical decision making. | Hepatica | PERSPECTUM LTD | |
12 | B545032000000 | 03-2000-00 | MRopen 0.5 T | ASG SUPERCONDUCTORS SPA | ||
13 | B50510130 | 1013 (vers 1.3) | IQM is quality assurance device for medical linear accelerators for verifying th IQM is quality assurance device for medical linear accelerators for verifying the treatment beam. | IQM Integral Quality Monitor | IRT SYSTEMS GMBH | |
14 | B501THINKQA010004 | 1.0.4 | 1.0.4 | Radiation therapy quality assurance and error detection software suite | ThinkQA, EPIbeam | DOSISOFT |
15 | B501THINKQA010002 | 1.0.2 | 1.0.2 | Radiation therapy quality assurance and error detection software suite | ThinkQA, EPIbeam | DOSISOFT |
16 | B501MU2NET020101 | 2.1.1 | 2.1.1 | MU2net is a standalone software device designed to perform secondary monitor uni MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems. | MU2net | DOSISOFT |
17 | B440HVCP030 | 030004 | HVCP | HeartVista Cardiac Package | HeartVista Cardiac Package | HEARTVISTA, INC. |
18 | B440HVCP020 | 020301 | HVCP | HeartVista Cardiac Package | HeartVista Cardiac Package | HEARTVISTA, INC. |
19 | B365805000 | 80-500 | Navigator CS | AKTINA CORP. | ||
20 | B365702100 | 70-210 | Prone Breast Immobilization System | AKTINA CORP. | ||
21 | B365702000 | 70-200 | SenoView Prone Breast System | AKTINA CORP. | ||
22 | B365701000 | 70-100 | SenoView Prone Breast Board | AKTINA CORP. | ||
23 | B365608120 | 60-812 | ArmCradle4 | AKTINA CORP. | ||
24 | B365605800 | 60-580 | ArmCradle3 | AKTINA CORP. | ||
25 | B365605600 | 60-560 | Arm Cradle | AKTINA CORP. | ||
26 | B365605500 | 60-550 | Foot Stabilizer | AKTINA CORP. | ||
27 | B365605450 | 60-545 | Indexing Bar | AKTINA CORP. | ||
28 | B365605430 | 60-543 | Adjustable Knee Support | AKTINA CORP. | ||
29 | B365605400 | 60-540 | Knee Support | AKTINA CORP. | ||
30 | B365605250 | 60-525 | Paddle | AKTINA CORP. | ||
31 | B365605220 | 60-522 | SBRT Universal Crossbar | AKTINA CORP. | ||
32 | B365605200 | 60-520 | Crossbar Assembly | AKTINA CORP. | ||
33 | B365605100 | 60-510 | Head Support System | AKTINA CORP. | ||
34 | B365605000 | 60-500 | Memorial Body Cradle | AKTINA CORP. | ||
35 | B365603120 | 60-312 | Respiratory Belt with Bladder, Large | AKTINA CORP. | ||
36 | B365603110 | 60-311 | Respiratory Belt with Bladder, Medium | AKTINA CORP. | ||
37 | B365603100 | 60-310 | Respiratory Belt with Bladder, Small | AKTINA CORP. | ||
38 | B365602800 | 60-280 | Localization Bridge | AKTINA CORP. | ||
39 | B365602300 | 60-230 | Wrist and Forearm Support | AKTINA CORP. | ||
40 | B365602200 | 60-220 | Hip-Knee-Foot Immobilizer | AKTINA CORP. | ||
41 | B365601900 | 60-190 | Belly Compression Arch Kit | AKTINA CORP. | ||
42 | B365601700 | 60-170 | PinPoint C-Spine Kit | AKTINA CORP. | ||
43 | B365601600 | 60-160 | Overhead Arm Support | AKTINA CORP. | ||
44 | B365601500 | 60-150 | Shoulder Restraint | AKTINA CORP. | ||
45 | B365601400 | 60-140 | Hand Grip | AKTINA CORP. | ||
46 | B365601200 | 60-120 | Crossbar Assembly | AKTINA CORP. | ||
47 | B365601100 | 60-110 | Frame Assembly | AKTINA CORP. | ||
48 | B365601000 | 60-100 | Memorial Body Cradle, Base System | AKTINA CORP. | ||
49 | B365579050 | 57-905 | Smart Tray, Siemens, Star Hole Pattern, Lexan, Cross-Hairs | AKTINA CORP. | ||
50 | B365579010 | 57-901 | Smart Tray, Siemens, Solid, Lexan, Cross-Hairs | AKTINA CORP. |