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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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HeRO ES - 00865536000210

No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000210 ()


  • Neonatal/paediatric heart rate monitoring application software
  • Neonatal/paediatric heart rate monitoring hardware

HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

Prelude - 04260308110108

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. EBRT
In Commercial Distribution

  • 04260308110108 ()


  • Radiation therapy software

Prelude - 04260308110092

The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1. IORT
In Commercial Distribution



  • Radiation therapy software

Prelude - 04260308110078

The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron. It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device. The machine parameters are not intended to be used for direct control for the radiation device. Machine Output Quality can be visualized and recorded over time for quality assurance.
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
V1.
In Commercial Distribution

  • 04260308110078 ()


  • Radiation therapy software

VeriSuite - 04260308110023

No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software

DIERS postura - 04260242060194

No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system

DIERS statico - 04260242060101

No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system

DIERS formetric - 04260242060019

No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372680

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system
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