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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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LUNA 3D - 04260590372598

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

  • 04260590372598 ()
0018364-0009

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372581

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

  • 04260590372581 ()
0018364-0008

  • Radiological video camera patient positioning/tracking system

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

VeriSuite - 04260308110023

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

  • 04260308110023 ()


  • 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

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

ART-Plan - 03770019940006

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

NA - 08717213053700

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

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


  • Radiation therapy software

NA - 08717213051881

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

  • 08717213051881 ()


  • Radiation therapy software

NA - 08717213051843

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

  • 08717213051843 ()


  • Radiation therapy software

NA - 08717213051782

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

  • 08717213051782 ()


  • Radiation therapy software

NA - 08717213051775

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

  • 08717213051775 ()


  • Radiation therapy software

NA - 08717213051294

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

  • 08717213051294 ()


  • Radiation therapy software

Radiation Planning Assistant (RPA) - 00040695000008

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

Mobius3D - 00899475002608

No Description
VARIAN MEDICAL SYSTEMS, INC.
3.1
In Commercial Distribution

  • 00899475002608 ()


  • Radiation therapy software

Mobius3D - 00899475002462

No Description
VARIAN MEDICAL SYSTEMS, INC.
2.2
In Commercial Distribution

  • 00899475002462 ()


  • Radiation therapy software

Varian Mobius 3D - 00899475002431

No Description
VARIAN MEDICAL SYSTEMS, INC.
2.1
In Commercial Distribution

  • 00899475002431 ()


  • Radiation therapy software

Varian FractionLab - 00899475002424

No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002424 ()


  • Radiation therapy software

Varian DoseLab Pro - 00899475002417

No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002417 ()


  • Radiation therapy software

Varian DoseLab TG-142 - 00899475002400

No Description
VARIAN MEDICAL SYSTEMS, INC.
7.0
In Commercial Distribution

  • 00899475002400 ()


  • Radiation therapy software

Theraview - 08717953004000

The Theraview software is used in radiation therapy clinics to acquire Megavoltage (MV) and/ or kiloVoltage (kV) images by means of an imaging device, using one of the Cablon Medical accessories EPID, DAR, eDAR or TBI, and perform image registration (i.e. image matching, tracking) or import match results, in order to accurately set up and position patients for treatment
Cablon Medical B.V.
C01-01-00
In Commercial Distribution

  • 08717953004000 ()
C01-01-00

  • Radiation therapy software

NA - 08717213053717

Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Nucletron B.V.
170538-00
In Commercial Distribution

  • 08717213053717 ()


  • Radiation therapy software

NA - 08717213052758

Oncentra External Beam Oncentra Brachy v4.6.1
Nucletron B.V.
170607-00
In Commercial Distribution

  • 08717213052758 ()


  • Radiation therapy software

NA - 08717213052321

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-08
In Commercial Distribution

  • 08717213052321 ()


  • Radiation therapy software

NA - 08717213052314

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-28
In Commercial Distribution

  • 08717213052314 ()


  • Radiation therapy software

NA - 08717213052307

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052307 ()


  • Radiation therapy software

NA - 08717213052291

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-27
Not in Commercial Distribution

  • 08717213052291 ()


  • Radiation therapy software

NA - 08717213052246

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052246 ()


  • Radiation therapy software

NA - 08717213052239

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-25
Not in Commercial Distribution

  • 08717213052239 ()


  • Radiation therapy software

NA - 08717213020610

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

  • 08717213020610 ()


  • Radiation therapy software

NA - 08717213038677

Oncentra External Beam v4.5
Nucletron B.V.
Oncentra External Beam
In Commercial Distribution

  • 08717213038677 ()


  • Radiation therapy software

NA - 08717213038660

Oncentra Brachy v4.5
Nucletron B.V.
Oncentra Brachy
In Commercial Distribution

  • 08717213038660 ()


  • Radiation therapy software

NA - 08717213037861

Oncentra Prostate v4.2 (including Oncentra Seeds)
Nucletron B.V.
Oncentra Prostate including Oncentra Seeds
In Commercial Distribution

  • 08717213037861 ()


  • Radiation therapy software

radiance - 08436567540017

Radiance V4 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
4
In Commercial Distribution

  • 08436567540017 ()


  • Radiation therapy software

radiance - 08436567540000

Radiance V3 is a software system intended for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Radiance V3 shall be clinically qualified radiation therapy staff trained in using the system.
GMV SOLUCIONES GLOBALES INTERNET SA
3
In Commercial Distribution

  • 08436567540000 ()


  • Radiation therapy software

Panther Brachy - 01868603000212

No Description
Prowess, Inc.
version 5.0
Not in Commercial Distribution

  • 01868603000212 ()


  • Radiation therapy software

Emprint - 10884521717411

Emprint Ablation Visualization Application V1.4
Covidien LP
CAVA
In Commercial Distribution

  • 10884521717411 ()


  • Radiation therapy software

Emprint - 10884521783928

Emprint Ablation Visualization Application V2.0
Covidien LP
CAVA
In Commercial Distribution

  • 10884521783928 ()


  • Radiation therapy software

syngo VSim - 04056869013077

No Description
Siemens Healthcare GmbH
10830856
In Commercial Distribution

  • 04056869013077 ()


  • Radiation therapy software

RT Elements - Multiple Brain Mets SRS - 04056481140946

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481140946 ()


  • Radiation therapy software

RT Elements - Dose Review - 04056481140700

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481140700 ()


  • Radiation therapy software

RT Elements - RT QA - 04056481140694

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481140694 ()


  • Radiation therapy software

Cranial Srs - 04056481140403

No Description
Brainlab AG
1.5
In Commercial Distribution

  • 04056481140403 ()


  • Radiation therapy software

RT QA - 04056481140397

No Description
Brainlab AG
1.5
Not in Commercial Distribution

  • 04056481140397 ()
21762-02A

  • Radiation therapy software

Spine Srs - 04056481140380

No Description
Brainlab AG
1.5
In Commercial Distribution

  • 04056481140380 ()


  • Radiation therapy software

Iplan Rt Dose, Iplan Rt Adaptive, Iplan Rt Phantom Qa, Iplan Rt Review - 04056481138608

No Description
Brainlab AG
4.5
In Commercial Distribution

21381E

  • Radiation therapy software

Physics Administration - 04056481131500

No Description
Brainlab AG
5.0
Not in Commercial Distribution

  • 04056481131500 ()
21762-02

  • Radiation therapy software
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