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The EPIONE® RoboKit™ is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
QUANTUM SURGICAL
09-0057
In Commercial Distribution
- 03760305400260 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE® RoboKit™ Plus is used during the CT guided procedures performed with EPIONE®.
Sterile drapes are used to cover:
the robotic arm,
the touchscreen of the display cart,
the tray of the display cart supporting the mouse and the keyboard.
Reflective spheres to be placed on the tracked EPIONE instruments tracked.
The EPIONE® RoboKit™ Plus includes the accessories individually packaged in their primary packaging considered as sterile, but the EPIONE® RoboKit™ Plus is not sterile.
QUANTUM SURGICAL
09-0046
In Commercial Distribution
- 03760305400253 ()
- Surgical optical-tracking spatial marker, single-use
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures
QUANTUM SURGICAL
30-0001
In Commercial Distribution
- 03760305400086 ()
30-0001-01-USA
- Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing
reference points or anatomical landmarks in the medical images. It allows the verification
of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution
- 03760305400079 ()
02-0044
- Robotic surgical navigation system
The Needle Guide is an instrument of the EPIONE device. It provides mechanical guidance for rigid straight instruments of a range of external diameter specified in the Technical Specifications.
QUANTUM SURGICAL
02-0027
In Commercial Distribution
- 03760305400062 ()
02-0027-19G
- Robotic surgical navigation system
The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification
of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution
- 03760305400055 ()
02-0031
- Robotic surgical navigation system
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
QUANTUM SURGICAL
30-0001 v1.0.2
In Commercial Distribution
- 03760305400031 ()
- Robotic surgical navigation system
The Patient Reference is an instrument of the EPIONE device used to track the patient
position and motions including breathing.
QUANTUM SURGICAL
02-0026
In Commercial Distribution
- 03760305400024 ()
02-0026
- Robotic surgical navigation system
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
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 Android.
Ai Nile Inc
Nile for Android
In Commercial Distribution
- 00850031821019 ()
- 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
Software application that uses machine learning to assess breast tissue composition.
Ai Whiterabbit Inc
WRDensity-1
In Commercial Distribution
- 00860005853601 ()
- Radiology DICOM image processing application software
Tempus ECG-AF is a cardiovascular machine learning-based notification software intended to analyze recordings of 12-lead ECG devices from patients 65 years of age and older. The software employs machine learning techniques to analyze ECG recordings and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. The device is designed to extract otherwise unavailable information from ECGs conducted under the standard of care, to help health care providers better identify patients who may be at risk for undiagnosed AF in order to evaluate them for referral of further diagnostic follow up and address the unmet need of reducing the number of undiagnosed AF patients.
Tempus AI, Inc.
3
In Commercial Distribution
- 00860011843603 ()
- Cardiopulmonary physiological parameter analysis software
No Description
Ezra Ai, Inc.
FLHAI01PL02IF01IT01LB02
In Commercial Distribution
- 00860010264621 ()
- Radiology DICOM image processing application software
No Description
Ezra Ai, Inc.
FLHAI00PL01IF00IT00LB01
In Commercial Distribution
- 00860010264614 ()
- Radiology DICOM image processing application software
Collection convenience kit to collect, contain, and ship a single human blood specimen to a Renalytix laboratory for kidneyintelX.dkd testing
Renalytix Ai, Inc.
RENX-3011087
In Commercial Distribution
- 00860009877931 ()
- General specimen collection kit
Test Report for the kidneyintelX.dkd test.
Renalytix Ai, Inc.
1
In Commercial Distribution
- 00860009877924 ()
- Kidney disease progression risk assessment interpretive software IVD
- Multiple chronic kidney disease (CKD) marker IVD, kit, chemiluminescent immunoassay
Collection kit used to collect, contain and ship human urine to a Renalytix clinical laboratory for uACR testing
Renalytix Ai, Inc.
RENX3011003
In Commercial Distribution
- 00860009877917 ()
- General specimen collection kit
Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX testing.
Renalytix Ai, Inc.
RENX-3011000
In Commercial Distribution
- 00860009877900 ()
- General specimen collection kit
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
STAR Apollo Mapping System
- Cardiac mapping system application software
The STAR Apollo Mapping System is a cardiac mapping method that is based on proprietary algorithms developed to identify localized sources of atrial activation during AF. The STAR Apollo Mapping System does not aim to elucidate the mechanism of AF, rather it seeks to reveal the anatomical location of regions where activation may be originating from, regardless of mechanism. This is based on a very simple and fundamental principle that the source of activation will have activation emerging from it in multiple directions, but not progressing towards it.
Rhythm AI Inc.
STAR Apollo Mapping System
Not in Commercial Distribution
- 00860009793507 ()
STAR Apollo Mapping System
- Cardiac mapping system application software
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
MAXQ AI LTD
V2.3 and subsequent minor V2.x releases
In Commercial Distribution
- 00860001219531 ()
- Radiology DICOM image processing application software
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
MAXQ AI LTD
V1.6
In Commercial Distribution
- 00860001219500 ()
ACC-IX0 V1.6 and V2.2
- Radiology DICOM image processing application software
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
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution
- 00628011382184 ()
- Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution
- 00628011382177 ()
- Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.6.0
In Commercial Distribution
- 00628011382160 ()
- Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.5.0
In Commercial Distribution
- 00628011382153 ()
- Radiation therapy software