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510(k) Data Aggregation
K Number
K190017Device Name
LiverMultiScan (LMSv3)
Manufacturer
Perspectum Diagnostics Ltd
Date Cleared
2019-06-27
(175 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Perspectum Diagnostics Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive 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 include 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.
Device Description
LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.
The main functionality of LiverMultiScan (LMSv3) includes:
- Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
- Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver.
- Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.
- Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1).
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K Number
K183133Device Name
MRCP+ v1.0
Manufacturer
Perspectum Diagnostics Ltd
Date Cleared
2019-01-09
(57 days)
Product Code
LLZ, PER
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Perspectum Diagnostics Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
MRCP+v1 is a standalone software device. The purpose of the MRCP+v1 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, typically a radiographer or technician trained in radiological anatomy, loads as input into the MRCP+v1 device previously acquired MRCP data. The device is intended to be used by a trained operator to generate metrics in the form of a summary report to enable reporting by a radiologist for subsequent interpretation and diagnosis by a clinician.
MRCP+v1 is designed to utilize DICOM 3.0 compliant MRCP datasets, acquired on supported MR scanners, to display the fluid-filled tubular structures in the abdomen, including the intra- and extrahepatic biliary tree, gallbladder and pancreatic ductal system.
Analysis and evaluation tools include:
- Segmentation of structures utilising user input of seeding points.
- Interactive labelling of segmented areas.
- Quantitative measurement derived from segmentation and labelling results.
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.
The radiologist may use existing radiological tools to report on the biliary tree. The reviewing radiologist needs to take into consideration the device's limitations and accuracy during review. The MRCP+v1 report is intended to supplement a conventional radiology report, for interpretation by a clinician.
MRCP+v1 does not replace the usual procedures for assessment of the biliary system by a reviewing radiologist or 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 input to radiologists and clinicians in addition to that provided by conventional MRCP.
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K Number
K172685Device Name
LiverMultiScan
Manufacturer
Perspectum Diagnostics Ltd
Date Cleared
2017-11-21
(76 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Perspectum Diagnostics Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiverMultiScan (LMSv2) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LiverMultiScan (LMSv2) 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 (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
Device Description
LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse.
LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow.
LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.
LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists.
LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan (LMSv2) offers the following.
- Advanced visualisation of MR data.
- Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage).
- Circular region of interest statistics.
- Snapshot of images to include in a report.
- Report to include region statistics, snapshot images and user-entered text.
- Export of snapshot images to report.
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