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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.
v0.4.0
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 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.
V0.1.4
In Commercial Distribution
- 00850012642015 ()
- MRI image interpretive 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
MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex,
such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.
Megin Oy
SW26241N
In Commercial Distribution
- 06430056480404 ()
- Magnetoencephalography system, superconducting
TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electro-encephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.
Megin Oy
NM27000N
In Commercial Distribution
- 06430056480411 ()
- Magnetoencephalography system, superconducting
MaxFilter™ is used with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUXTM neo in suppressing magnetic interference and in reducing measurement artifacts.
Megin Oy
SW24051N
In Commercial Distribution
- 06430056480039 ()
- Magnetoencephalography system, superconducting
Magnetoencephalography system (MEG), 275 channel
CTF MEG International Services Limited Partnership
CTF MEG 275
In Commercial Distribution
- B956CO0275110 ()
CO-0275-1-1
- Magnetoencephalography system, superconducting
No Description
RICOH COMPANY,LTD.
RICOH160-1
In Commercial Distribution
- 04961311926266 ()
- Magnetoencephalography system, superconducting
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497817
Not in Commercial Distribution
- 10886333215062 ()
- 00886333215065 ()
- 20886333215069 ()
- 5F
497817
- Magnetocardiography system
4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497816
Not in Commercial Distribution
- 10886333215055 ()
- 00886333215058 ()
- 20886333215052 ()
- 4F
497816
- Magnetocardiography system
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497814
Not in Commercial Distribution
- 10886333215048 ()
- 00886333215041 ()
- 20886333215045 ()
- 5F
497814
- Magnetocardiography system
4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497813
Not in Commercial Distribution
- 10886333215031 ()
- 00886333215034 ()
- 20886333215038 ()
- 4F
497813
- Magnetocardiography system
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497812
In Commercial Distribution
- 10886333215024 ()
- 00886333215027 ()
- 20886333215021 ()
- 5F
497812
- Magnetocardiography system
4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497811
Not in Commercial Distribution
- 10886333215017 ()
- 00886333215010 ()
- 20886333215014 ()
- 4F
497811
- Magnetocardiography system
5F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497802
In Commercial Distribution
- 10886333215000 ()
- 00886333215003 ()
- 20886333215007 ()
- 5F
497802
- Magnetocardiography system
4F Percutaneous Micro-Introducer Kit
ARGON MEDICAL DEVICES, INC.
497801
In Commercial Distribution
- 10886333214997 ()
- 00886333214990 ()
- 20886333214994 ()
- 4F
497801
- Magnetocardiography system
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
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
AI AT Compression Screws Tray Assembly
Acumed LLC
AI-1520
In Commercial Distribution
- 10806378054716 ()
- Orthopaedic implant/instrument assembling device
AI Female Fitting Ass'y nonperm clips
Avalign Technologies, Inc.
M152332
In Commercial Distribution
- 00190776189648 ()
- Electrical-only medical device connection cable, reusable
FIBEROPTIC LIGHT CABLE ADAPTER FOR AI
Avalign Technologies, Inc.
72-52310
In Commercial Distribution
- 00190776208738 ()
- Rigid endoscopic tissue manipulation forceps, reusable
SW ZA420 ACCURHYTHM AI ALGORITHM PAUSE
MEDTRONIC, INC.
ZA420
In Commercial Distribution
- 00763000504533 ()
- Implantable cardiac device management application software
SW ZA410 ACCURHYTHM AI ALGORITHM AF
MEDTRONIC, INC.
ZA410
In Commercial Distribution
- 00763000504526 ()
- Implantable cardiac device management application software