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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The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution

  • 00866498000300 ()
Ray 5.0

  • Radiation therapy software
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
In Commercial Distribution

  • 04260590372680 ()
0018365-0001

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372673 ()
0018440

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372666 ()
0018438

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
Central Server host PC Luna 3D
In Commercial Distribution

  • 04260590372659 ()
0018439-0001

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372642 ()
0018346-0003

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372635 ()
0018346-0002

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372628 ()
0018440

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372611 ()
0018438

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Camera Pod
Not in Commercial Distribution

  • 04260590372604 ()
0018914

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372598 ()
0018364-0009

  • Radiological video camera patient positioning/tracking system
No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system
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
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
No Description
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
1.8
In Commercial Distribution

  • 04260308110023 ()


  • Radiation therapy software
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
No Description
DIERS International GmbH
n/a
In Commercial Distribution

  • 04260242060194 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
II
In Commercial Distribution

  • 04260242060101 ()


  • Radiological video camera patient positioning/tracking system
No Description
DIERS International GmbH
III 4D
In Commercial Distribution

  • 04260242060019 ()


  • Radiological video camera patient positioning/tracking system
The current version of the medical device includes the Annotate and the SmartFuse module that intends to help the practitioner to delineate organs at risks manually, semi-automatically and automatically. The Smartfuse module is also providing the possibility to do a fusion of images from different modalities. This version also contains an administration module, that allows the user to manage data and rights.
THERAPANACEA
v.1.10.0
In Commercial Distribution

  • 03770019940006 ()


  • Radiation therapy software
Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170018-00
In Commercial Distribution

  • 08717213053700 ()
  • 08717213054004 ()
  • 08717213053991 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-05
Not in Commercial Distribution

  • 08717213051881 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-24
Not in Commercial Distribution

  • 08717213051843 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-04
Not in Commercial Distribution

  • 08717213051782 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software
Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213051294 ()


  • Radiation therapy software
The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks. The system is intended for use for patients with cancer of the head and neck, cervix, breast, and metastases to the brain. The RPA system is integrated with the Eclipse Treatment Planning System v15.6 software cleared under K181145. The RPA radiation treatment planning software tool was trained against hundreds / thousands of CT Scans of normal and diseased tissues from patients receiving radiation for head and neck, cervical, breast, and whole brain at MD Anderson Cancer Center.
The University of Texas M. D. Anderson Cancer Center
1.0.0.5
In Commercial Distribution

  • 00040695000008 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
3.1
In Commercial Distribution

  • 00899475002608 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.2
In Commercial Distribution

  • 00899475002462 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00899475002431 ()


  • Radiation therapy software
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