Who is the manufacturer of CDM Insights?

Oxford Brain Diagnostics, Ltd. filed the 510(k) submission for CDM Insights (K240680).

What is the FDA product code for CDM Insights?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CDM Insights?

510(k) clearance (submission type: Traditional).

Does CDM Insights use AI or machine learning?

Yes. CDM Insights (K240680) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for CDM Insights?

Al-Rad Companion Brain MR (K213706); OnQ Neuro (K210831).

Who can help prepare an FDA 510(k) submission like CDM Insights?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like CDM Insights get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

CDM Insights

K240680 · Oxford Brain Diagnostics, Ltd. · QIH · Dec 6, 2024 · Radiology

Device Facts

Record ID	K240680
Device Name	CDM Insights
Applicant	Oxford Brain Diagnostics, Ltd.
Product Code	QIH · Radiology
Decision Date	Dec 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

CDM Insights is a post-processing image analysis software that assists trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age. CDM Insights provides the following functionalities: - Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities - Quantitative comparison of brain structures and derived values with normative data from a healthy population - Presentation of results for reporting that includes numerical values as well as visualization of these results

Device Story

CDM Insights is post-processing software for MR brain images; accepts DICOM inputs. Performs automated segmentation/quantification of brain structures and white matter hyperintensities; conducts post-acquisition analysis of diffusion-weighted imaging (DWI) data; compares patient metrics against normative data from healthy populations. Deployed as a cloud solution; produces DICOM-encapsulated PDF reports with numerical values, graphs, and anatomical color overlays. Used by radiologists and neurologists to assist in clinical evaluation; output supports clinical decision-making by providing quantitative brain morphometry and lesion data. Benefits include standardized, objective assessment of brain structures and longitudinal tracking of metrics.

Clinical Evidence

Bench testing only. Accuracy of segmentation and cortical surfaces validated against gold standard (US board-certified neuroradiologists) using 60 cases (healthy, Alzheimer's, MCI, frontotemporal dementia, MS). Mean Dice overlap for white matter hyperintensities was 0.66 (SD 0.15), exceeding 0.58 criterion. Regional cortical Dice scores ranged 0.58-0.72, all passing 0.58 threshold. Repeatability tested on 121 individuals; reproducibility tested on >1500 subjects (aged 45-90). Percentile accuracy tested on ~2000 independent scans.

Technological Characteristics

Medical image management and processing software. Cloud-based deployment. Inputs: DICOM MR images (T1-weighted, FLAIR, DWI). Outputs: DICOM-encapsulated PDF reports, numerical data, color overlays. Complies with ISO 13485, ISO 14971, IEC 62304. Software-based segmentation and quantification algorithms.

Indications for Use

Indicated for trained healthcare practitioners (radiologists, neurologists) to view, analyze, and evaluate MR brain images of adults > 45 years of age.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

Al-Rad Companion Brain MR (K213706)
OnQ Neuro (K210831)

Related Devices

K250416 — GBrain MRI · Galileo Cds, Inc. · Apr 11, 2025
K193287 — CorInsights MRI · Adm Diagnostics, Inc. · Nov 20, 2020
K213253 — Pixyl.Neuro · Pixyl SA · Jun 30, 2023
K230913 — ANDI · Imeka Solutions, Inc. · Jul 25, 2023
K170981 — NeuroQuant · Cortechs Labs, Inc. · Sep 7, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 6, 2024 Oxford Brain Diagnostics Ltd % Yulia Nikova Regulatory Affairs Manager Ken Blocking Consulting LLC 3400 N Central Expy Suite #110-225 Richardson, Texas 75080 Re: K240680 Trade/Device Name: CDM Insights Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 4, 2024 Received: November 5, 2024 # Dear Yulia Nikova: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, D. R. X. Daniel M. Krainak, PhD Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240680 Device Name CDM Insights Indications for Use (Describe) CDM Insights is a post-processing image analysis software that assists trained healthcare practitioners in viewing. analyzing, and evaluating MR brain images of adults > 45 years of age. CDM Insights provides the following functionalities: - · Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities - · Quantitative comparison of brain structures and derived values with normative data from a healthy population - · Presentation of results for reporting that includes numerical values as well as visualization of these results | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for Oxford Brain Diagnostics. The logo features a stylized brain graphic on the left, composed of interconnected circles in white and gray, with one circle in orange. To the right of the brain graphic, the text "oxford brain diagnostics" is written in white against a dark blue background. The text is in a sans-serif font, with "oxford brain" on the first line and "diagnostics" on the second line. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR §807.92. | Applicant/ Sponsor: | Oxford Brain Diagnostics Ltd The Oxford Centre for Innovation New Road, Oxford. OX1 1BY United Kingdom | | | |------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------|--| | Contact Person: | Terry Pollard Chief Operating Officer TEL: +44 (0)1865 261400 | | | | Date Prepared: | December 3rd, 2024 | | | | Subject Device: | Manufacturer: | Oxford Brain Diagnostics Ltd | | | | Trade Name: | CDM Insights | | | | Product Name: | CDM Insights | | | | Classification Name: | Medical Image Management and Processing System | | | | Classification Panel: | Radiology | | | | Product Code: | QIH | | | | Regulation: | 21 CFR §892.2050 | | | | Class: | II | | | | Prescription or OTC Use: | Rx | | | Predicate Device: | Clearance: | K213706 | | | | Clearance Date: | April 15, 2022 | | | | Manufacturer: | Siemens Healthcare GmbH | | | | Trade Name: | Al-Rad Companion Brain MR | | | | Product Name: | Al-Rad Companion Brain MR | | | | Classification Name: | Medical Image Management and Processing System | | | | Classification Panel: | Radiology | | | | Product Code: | QIH | | | | Regulation: | 21 CFR §892.2050 | | | | Class: | II | | | | Prescription or OTC Use | Rx | | Device CDM Insights is automated post-processing medical device software Description: that is used by radiologists, neurologists, and other trained healthcare practitioners familiar with the post-processing of magnetic resonance images. It accepts DICOM images using supported protocols and performs: automatic segmentation and quantification of brain structures and lesions, automatic post-acquisition analysis of diffusionweighted magnetic resonance imaging (DWI) data, and comparison of derived image metrics from multiple time-points. > The values for a given patient are compared against age-matched percentile data from a population of healthy reference subjects. White matter hyperintensities can be visualized and quantified by volume. Output of the software provides numerical values and derived data as graphs and anatomical images with graphical color overlays. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Oxford Brain Diagnostics. The logo consists of a stylized brain graphic on the left, with the words "oxford brain diagnostics" to the right of the graphic. The brain graphic is made up of interconnected circles, some of which are white, gray, and one orange. The text is in a sans-serif font and is white. CDM Insights output is provided in standard DICOM format as a DICOMencapsulated PDF report. Indications for CDM Insights is a post-processing image analysis software that assists Use: trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age. CDM Insights provides the following functionalities: - Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities - . Quantitative comparison of brain structures and derived values with normative data from a healthy population - . Presentation of results for reporting that includes numerical values as well as visualization of these results Summary of Technological Characteristics: The following aspects of the subject CDM Insights device and the predicate devices are identical: - Intended Use - Technological Principle - Device Classification Name ● - . Classification Panel - Regulation Number - Product Code - Classification - Prescription Use The Indications for Use and Intended Users for the CDM Insights device and the Al-Rad Companion Brain MR device use only slightly different wording: - . The CDM Insights devices refers to "healthcare practitioners" whereas the Al-Rad Companion Brain MR refers to "clinicians" in the Indications for Use and "healthcare professionals" in the Intended Users. We consider these to be equivalent. In our Instructions for Use we have, in the same way as our primary predicate, clarified our definition of healthcare practitioners to include "radiologists, neurologists, and other trained healthcare practitioners familiar with the post-processing of magnetic resonance images". The following features are substantially equivalent between the CDM Insights device and the Al-Rad Companion Brain MRI device (the CDM Insights Device presents percentiles, whereas the Al-Rad Companion Brain MRI device presents z-scores): - Brain Morphometry Segmentation - Brain Morphometry Quantification - Brain Morphometry: Deviation Map ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Oxford Brain Diagnostics. The logo features a stylized brain graphic on the left, composed of interconnected circles in white, gray, and orange. To the right of the brain graphic, the text "oxford brain diagnostics" is written in a sans-serif font. The background of the image is a dark blue color. | | New Device | Predicate Device | Additional Predicate Device | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | CDM Insights | Al-Rad Companion Brain MR | OnQ Neuro | | 510(k) Submitter [Number] | Oxford Brain Diagnostics Ltd | Siemens Healthcare GmBh | CorTechs Labs, Inc | | 510(k) Number | K240680 | K213706 | K210831 | | Indications for Use | CDM Insights is a post- processing image analysis software that assists trained healthcare practitioners in viewing, analyzing, and evaluating MR brain images of adults > 45 years of age. CDM Insights provides the following functionalities: - Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities - Quantitative comparison of brain structures and derived values with normative data from a healthy population - Presentation of results for reporting that includes numerical values as well as visualization of these results | Al-Rad Companion Brain MR is a post- processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images. Al-Rad Companion Brain MR provides the following functionalities: - Automatic segmentation and quantitative analysis of individual brain structures and white matter hyperintensities - Quantitative comparison of each brain structure with normative data from a healthy population - Presentation of results for reporting that includes all numerical values as well as visualization of these results | OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. OnQ Neuro is intended to provide automatic segmentation, quantification, and reporting of derived image metrics. OnQ Neuro is additionally intended to provide automatic fusion of derived parametric maps with anatomical MRI data. OnQ Neuro is intended for use on brain tumors, which are known/confirmed to be pathologically diagnosed cancer. OnQ Neuro is intended for comparison of derived image metrics from multiple time- points. The physician retains the ultimate responsibility for making the final diagnosis and treatment decision. | | Intended Users | The device is intended for healthcare practitioners familiar with the post- processing of magnetic resonance images | The device is intended for healthcare professionals familiar with the post processing of magnetic resonance images | Radiologists, Oncologists | | Technological Principle | Software | Software | Software | | Device Description | CDM Insights is automated post-processing medical device software that is used by radiologists, neurologists, and other trained healthcare practitioners familiar with the post-processing of magnetic resonance images. It accepts DICOM images using supported protocols and performs: | Al-Rad Companion Brain MR VA40 is an enhancement to the predicate, Al-Rad Companion Brain MR VA20 (K193290). Just as in the predicate, Al-Rad Companion Brain MR addresses the automatic quantification and visual assessment of the volumetric properties of various brain structures based on T1 MPRAGE datasets. In Al- | OnQ Neuro is a fully automated post-processing medical device software that is used by radiologists, oncologists, and other clinicians to assist with analysis and interpretation of neurological MR images. It accepts DICOM images using supported protocols and performs 1) automatic segmentation and volumetric quantification of brain tumors | | Trade Name | New Device | Predicate Device | Additional Predicate Device | | | CDM Insights | Al-Rad Companion Brain MR | OnQ Neuro | | | automatic segmentation and quantification of brain structures and lesions, automatic post-acquisition analysis of diffusion- weighted magnetic resonance imaging (DWI) data, and comparison of derived image metrics from multiple time-points. The values for a given patient are compared against age-matched percentile data from a population of healthy reference subjects. White matter hyperintensities can be visualized and quantified by volume. Output of the software provides numerical values and derived data as graphs and anatomical images with graphical color overlays. CDM Insights output is provided in standard DICOM format as a DICOM-encapsulated PDF report. | Rad Companion Brain MR VA40, the quantification and visual assessment extends to white matter hyperintensities on the basis of T1 MPRAGE and T2 weighted FLAIR datasets. These datasets are acquired as part of a typical head MR acquisition. The results are directly archived in PACS as this is the standard location for reading by radiologist. From a predefined list of 30 structures (e.g. Hippocampus, Left Frontal Grey Matter, etc.), volumetric properties are calculated as absolute and normalized volumes with respect to the total intercranial volume. The normalized values for a given patient are compared against age-matched mean and standard deviations obtained from a population of healthy reference subjects. The white matter hyperintensities can be visualized as a 3D overlay map and the quantification in count and volume as per 4 brain regions in the report. As an update to the previously cleared device, the following modifications have been made: 1. Modified Intended Use Statement 2. Addition of white matter hyperintensities overlay map, count and volume as per 4 brain regions 3. Enhanced DICOM Structured Report (DICOM SR) 4. Updated deployment structure | which are known/confirmed to be pathologically diagnosed cancer, 2) automatic post- acquisition analysis of diffusion- weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical MR images, and 3) comparison of derived image metrics from multiple time- points. Output of the software provides values as numerical volumes, and images of derived data as grayscale intensity maps and as graphical color overlays on top of the anatomical image. OnQ Neuro output is provided in standard DICOM format as image series and reports that can be displayed on most third-party commercial DICOM workstations | | Brain Morphometry Segmentation | Pre-processing functionality for automatic segmentation and volumetry of T1-weighted | Pre-processing functionality for automatic segmentation and volumetry of MPRAGE data | Software performs automatic segmentation | | Trade Name | New Device | Predicate Device | Additional Predicate Device | | CDM Insights | MRI data, e.g. MPRAGE or similar acquisition data. | Al-Rad Companion Brain MR | OnQ Neuro | | | | | | | Brain Morphometry Quantification | Calculation of label maps (display of brain segmentation) and partially combined label maps (fused with the processed T1-weighted MRI data, e.g. MPRAGE or similar acquisition. | Calculation of label maps (display of brain segmentation) and partially combined label maps (fused with the processed MPRAGE data). | Software performs automatic quantification | | Brain Morphometry: Deviation Map | Calculation of deviation map (representation of brain status in relation to reference data) and partially combined deviation maps (fused with the processed T1- weighted MRI data, e.g. MPRAGE or similar acquisition) | Calculation of deviation map (representation of brain status in relation to reference data) and partially combined deviation maps (fused with the processed MPRAGE data) User customizable color labels for the overlay map | Unknown | | Diffusion Analysis | Yes, using a single- compartment diffusion model. | No | Yes, using single and multi- compartment diffusion models. | | Support Longitudinal Analysis | Yes, performs comparison of derived image metrics from multiple time points | No | Yes, performs comparison of derived image metrics from multiple time points. | | Brain White Matter Hyperintensities Segmentation | Pre-processing functionality for automatic segmentation and volumetry of T1-weighted data, that includes MPRAGE or similar acquisition, and FLAIR data. (volumetry of white matter hypointensities if FLAIR data is not available) | Pre-processing functionality for automatic segmentation and volumetry of MPRAGE and FLAIR data. | Information on White Matter Hyperintensities is not provided. | | Brain White Matter Hyperintensities Quantification | Calculation of white matter hyperintensities volume (white matter hypointensities volume if FLAIR data is not available). | Calculation of white matter hyperintensities count and volume as per 4 brain regions.…