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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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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
In Commercial Distribution

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
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
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
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