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The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.6.0
In Commercial Distribution
- 00850012642053 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.5.0
In Commercial Distribution
- 00850012642046 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.4.0
In Commercial Distribution
- 00850012642039 ()
- MRI image interpretive software
The Avenda Health Unfold AI Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health Unfold AI Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate.
Avenda Health, Inc.
v0.3.0
- MRI image interpretive software
The CogNet AI-MT is a standalone software medical device for screening FFDM mammograms. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Medcognetics Inc
MT
In Commercial Distribution
- 00860007434709 ()
- X-ray image interpretive software
No Description
Icad, Inc.
2.1
In Commercial Distribution
- 00858012005960 ()
- Basic diagnostic x-ray system application software
AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including:
• Manual annotation tools for users to select regions of interest (ROIs),
• Semi-automatic lesion segmentation suggestions for user-selected ROIs,
• Automatic measurement and display of long and short axis of segmented lesions,
• Automatic tabulation and summation of measurements,
• Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality),
• Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and
• Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.
Ai Metrics, LLC
1
In Commercial Distribution
- G090AIM11 ()
AIM1
- Radiological PACS software
PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.
Exini Diagnostics AB
02
In Commercial Distribution
- 07350002336021 ()
602
- Radiology DICOM image processing application software
PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.
Exini Diagnostics AB
01
Not in Commercial Distribution
- 07350002336014 ()
601
- Radiology DICOM image processing application software
Amsco Quantum AdapterAmsco Quantum Adtr. Rigid
DEROYAL INDUSTRIES, INC.
AM3-R
In Commercial Distribution
- 50749756954575 ()
- 00749756954570 ()
- Instrument/equipment drape, single-use, sterile
Amsco Quantum AdapterAmsco Quantum Adtr. Flex
DEROYAL INDUSTRIES, INC.
AM3
In Commercial Distribution
- 50749756954568 ()
- 00749756954563 ()
- Instrument/equipment drape, single-use, sterile
ClariPlatform (Ver. ClariSuite View) is a medical imaging platform that hosts clinical AI solutions and provides user interface in an on-premise environment.
The system facilitates the networking, filtering, routing, and optional de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow. Additionally the system allows users to interact with the AI analysis results including confirming, rejecting, and selecting other category than provided by AI.
While ClariPlatform (Ver.1.0) operates as a cloud-based system, ClariPlatform (Ver. ClariSuite View) is specifically designed for on-premise deployment, ensuring compliance with institutional security policies, regulatory requirements, and data privacy concerns. ClariPlatform (Ver. ClariSuite View) is deployed within anorganization’s internal infrastructure, allowing healthcare providers to maintain full control over medical imaging data while leveraging advanced AI-assisted visualization tools.
Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
ClariSuite View
In Commercial Distribution
- 08800046800167 ()
- Radiological image interpretive software sharing portal
ClariPlatform (Ver. 1.0) is a medical imaging platform that hosts clinical AI solutions in a cloud-based SaaS format.
The system facilitates the networking, filtering, routing, and de-identification of medical image data between imaging systems, allowing users to easily execute AI solutions on-demand or integrate them into their clinical workflow.
ClariPlatform is only deployed on the cloud, ensuring accessibility and compliance with regulations.
Clinical AI solutions refer to separate medical device software and are not included within the scope of this system.
ClariPI Inc.
1.0
In Commercial Distribution
- 08800046800150 ()
- Radiological image interpretive software sharing portal
An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
Terarecon Inc.
Eureka AI Interoperability Platform
In Commercial Distribution
- B220843002A8430031 ()
- Radiological image interpretive software sharing portal
EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.
MYCARDIUM AI LIMITED
01.01.00(USA)
In Commercial Distribution
- 05061038730050 ()
EchoConfidence
- Cardiac mapping system application software
1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions
MYCARDIUM AI LIMITED
010002
In Commercial Distribution
- 05061038730036 ()
1CMR Pro
- MRI image interpretive software
A digital epilepsy care management web portal for HCP.
Ai Nile Inc
Nile for HCPs
In Commercial Distribution
- 00850031821026 ()
- Medication reminder application software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution
- 00850031821002 ()
- Medication reminder application software
A digital epilepsy care management platform application for Android.
Ai Nile Inc
Nile for Android
In Commercial Distribution
- 00850031821019 ()
- Medication reminder application software
Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment planning workflows. The system includes processing tools for automatically contouring of imaging data of supported modalities CT and MRI using machine learning based algorithms. The produced segmentation templates for regions of interest are intended to be transferred to appropriate image visualization systems to be used as a template for a medical professional to visualize, modify and approve prior to further use in clinical workflows.
The system supports automatic contouring of pre-defined structures from common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis.
Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
Mvision AI Oy
1.2
In Commercial Distribution
- 06429830064206 ()
- Image segmentation application software