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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
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
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
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