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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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iGUIDE Software 2.2.1 is the software which controls the movement of the HexaPOD™ evo Module and monitors the correct position of the module.
3C-Medical Intelligence GmbH
P10603-110
In Commercial Distribution

  • 04056719001742 ()
P10603-110

  • Accelerator system table, powered
No Description
Onera B.V.
01.00
In Commercial Distribution

  • 08720256698197 ()
ONERA STS1 STATION SOFTWARE

  • Polysomnography analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2
In Commercial Distribution

  • 07290110255022 ()
HASP-SW-K-S2I2-01

  • Patient-administration information system application software
  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I3-D1
In Commercial Distribution

  • 07290110252816 ()
HASP-SW-K-S2I3D1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Resting-ECG Measurement - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1-D1
In Commercial Distribution

  • 07290110252809 ()
HASP-SW-K-S2I1D1-01

  • Cardiopulmonary stress exercise monitoring system computer
  • Cardiovascular risk evaluation interpretive software
  • Patient-administration information system application software
Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): - D1 = ECG Management System NEMS - S2 = Advanced Stress-Test ECG - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2-D1
In Commercial Distribution

  • 07290110252601 ()
HASP-SW-K-S2I2D1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information.
RADLINK, INC.
PACS-SW
In Commercial Distribution

  • 00864908000117 ()


  • Radiology picture archiving and communication system digital archive device
No Description
CANON INC.
Ophthalmic Software Platform RX
In Commercial Distribution

  • 04549292084696 ()


  • Posterior eye segment analyser software
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi- Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.
VISIBLE PATIENT
1.0.19
In Commercial Distribution

  • VPS1019 ()


  • Radiology picture archiving and communication system digital archive device
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi- Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.
VISIBLE PATIENT
1.0.17
In Commercial Distribution

  • B373VPS10170 ()


  • Radiology picture archiving and communication system digital archive device
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