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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CXR software versions 2.4.X+ Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
CXR - 2.4+
In Commercial Distribution

  • G140ANNALISECONTAINER60 ()
Annalisecontainer6

  • X-ray image interpretive software
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Pride Mobility Products Corp
Quantum Outback
In Commercial Distribution

  • 00606509200240 ()
N/A

  • Electric-motor-driven wheelchair, occupant-controlled
No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
Not in Commercial Distribution

  • 08034055296752 ()
2501019

  • Electrosurgical system generator
No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
In Commercial Distribution

  • 08034055291184 ()
  • 08034055298190 ()
2501019

  • Electrosurgical system generator
No Description
TELEA ELECTRONIC ENGEENERING SRL
VESALIUS QUANTUM
Not in Commercial Distribution

  • 08034055290163 ()
2501019

  • Electrosurgical system generator
No Description
R.J.L. SCIENCES, INC.
Quantum Legacy
In Commercial Distribution

  • B202QL0 ()
QL

  • Bioelectrical body composition analyser
No Description
R.J.L. SCIENCES, INC.
Quantum 7
In Commercial Distribution

  • B202Q70 ()
Q7

  • Bioelectrical body composition analyser
No Description
R.J.L. SCIENCES, INC.
Quantum Desktop
In Commercial Distribution

  • B202QDT0 ()
QDT

  • Bioelectrical body composition analyser
Radiological imaging system transport kit
ECHONOUS, INC.
P006200
In Commercial Distribution

  • 09353278000229 ()


  • Radiological imaging system transport kit
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977275 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977268 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00856100006233 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00856100006172 ()


  • Radiation therapy software
OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software
inHEART MODELS AI is a medical image processing software for automatic 3D modelling, used to pre-process medical images (acquired only by CT devices). inHEART Models AI results are intended to be reviewed and, if needed, edited by inHEART trained staff with inHEART Models Shaper. inHEART MODELS AI is part of inHEART MODELS that is intended to provide qualified medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. The software is designed to be used by qualified medical professionals (including physicians, cardiologists, radiologists, and technicians) and the clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.1.0
In Commercial Distribution

  • 03770019599075 ()


  • Image segmentation application software
No Description.
Quantib B.V.
2.8
In Commercial Distribution

  • 08719689791308 ()


  • Radiology DICOM image processing application software
No description.
Quantib B.V.
2.7
In Commercial Distribution

  • 08719689791285 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.6
Not in Commercial Distribution

  • 08719689791247 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.5
In Commercial Distribution

  • 08719689791193 ()


  • Radiology DICOM image processing application software
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