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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
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
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
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
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