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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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Public API that allows access by authorized third parties to select Dexcom data
Dexcom, Inc.
SW13183
In Commercial Distribution

  • 00386270000668 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
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
STarFix™ Designer DBS
FHC, INC.
C0265-01-00922
In Commercial Distribution

  • 00873263009222 ()
C0265-01

  • Stereotactic neuronavigation/planning system
STarFix™ Designer Laptop, 1x
FHC, INC.
C0267-00917
In Commercial Distribution

  • 00873263009178 ()
C0267

  • Stereotactic neuronavigation/planning system
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution

  • 00860000249539 ()


  • Self-care monitoring/reporting software
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution

  • 00860000249522 ()


  • Self-care monitoring/reporting software
Onduo Care Team Console
VERILY LIFE SCIENCES LLC
SW0002
In Commercial Distribution

  • 00860000249515 ()


  • Self-care monitoring/reporting software
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution

  • 00860006956004 ()


  • Radiation therapy treatment planning workstation
No Description
PathAI, Inc.
11124001
In Commercial Distribution

  • 00860006696221 ()


  • Histology/cytology/microbiology image-analysis interpretive software IVD
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution

  • 00860005388189 ()
20104

  • Bioelectrical signal analysis software
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