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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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No Description
Siemens Healthcare GmbH
11582982
In Commercial Distribution

  • 04056869298207 ()


  • Radiology DICOM image processing application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431553
In Commercial Distribution

  • 04056869279800 ()


  • SPECT system application software
  • PET system application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11545289
In Commercial Distribution

  • 04056869274638 ()


  • Radiology DICOM image processing application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11294432
Not in Commercial Distribution

  • 04056869257952 ()


  • Radiology DICOM image processing application software
Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon.
Brainlab AG
3.0
In Commercial Distribution

  • 04056481142032 ()


  • Implantable electrical stimulation device management software
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909541 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution

  • 00190198909534 ()


  • Cardiopulmonary physiological parameter analysis software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution

  • 08720387058044 ()


  • X-ray image interpretive software
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