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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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Standard Imaging IMSure 3D - 00850019946543

Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91365
In Commercial Distribution

  • 00850019946543 ()
91365

  • Radiation therapy software

3D Brachy Application - 00860007402326

3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402326 ()


  • Radiation therapy software

3D Bolus Application - 00860007402319

3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution

  • 00860007402319 ()


  • Radiation therapy software

3D Bolus Software - 00860007402302

3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution

  • 00860007402302 ()


  • Radiation therapy software

Oncospace - 00860004284901

No Description
Oncospace, Inc.
System
In Commercial Distribution

  • 00860004284901 ()


  • Radiation therapy software

Panther TPS - 00868603000236

The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases.
Prowess, Inc.
version 5.51
Not in Commercial Distribution

  • 00868603000236 ()


  • Radiation therapy software

RadCalc® - 00867520000206

RadCalc® #1 Trusted Dosimetric Verification Software. RadCalc Software. LifeLine Software, Inc.
LIFELINE SOFTWARE INC
RadCalc®
In Commercial Distribution

  • 00867520000206 ()


  • Radiation therapy software

TCL3 Motion Tracking System - 05745000363018

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363018 ()

  • Height: 700 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system

Aqua - 00858164002381

No Description
Elekta Solutions AB
3.0.2
In Commercial Distribution

  • 00858164002381 ()


  • Radiation therapy software

Monaco - 00858164002275

No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 00858164002275 ()


  • Radiation therapy software

Monaco - 00858164002268

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002268 ()


  • Radiation therapy software

Monaco - 00858164002244

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002244 ()


  • Radiation therapy software

ERGO Localizer - 00858164002213

No Description
ELEKTA, INC.
ERGO Localizer
Not in Commercial Distribution

  • 00858164002213 ()


  • Radiation therapy software

ERGO++ - 00858164002206

No Description
ELEKTA, INC.
ERGO++
Not in Commercial Distribution

  • 00858164002206 ()


  • Radiation therapy software

Monaco - 00858164002190

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002190 ()


  • Radiation therapy software

Monaco - 00858164002183

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002183 ()


  • Radiation therapy software

Monaco - 00858164002169

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002169 ()


  • Radiation therapy software

Monaco - 00858164002152

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002152 ()


  • Radiation therapy software

XiO - 00858164002114

No Description
ELEKTA, INC.
XiO
Not in Commercial Distribution

  • 00858164002114 ()


  • Radiation therapy software

Monaco - 00858164002046

No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002046 ()


  • Radiation therapy software

Atlas-Based Autosegmentation - 00858164002039

No Description
ELEKTA, INC.
Atlas-Based Autosegmentation
Not in Commercial Distribution

  • 00858164002039 ()


  • Radiation therapy software

Panther TPS - 00859032007279

Panther TPS 6.0
Prowess, Inc.
6.0
In Commercial Distribution

  • 00859032007279 ()


  • Radiation therapy software

Panther TPS - 00859032007255

Panther TPS 5.9
Prowess, Inc.
5.9
In Commercial Distribution

  • 00859032007255 ()


  • Radiation therapy software

Panther TPS - 00859032007231

Panther TPS 5.81
Prowess, Inc.
5.81
In Commercial Distribution

  • 00859032007231 ()


  • Radiation therapy software

Panther TPS - 00859032007200

Panther TPS 5.8
Prowess, Inc.
5.8
Not in Commercial Distribution

  • 00859032007200 ()


  • Radiation therapy software

Panther TPS - 00859032007194

Panther TPS 5.7 DCP2
Prowess, Inc.
5.7
Not in Commercial Distribution

  • 00859032007194 ()


  • Radiation therapy software

Panther TPS - 00859032007170

Panther TPS 5.7 DCP
Prowess, Inc.
5.7
Not in Commercial Distribution

  • 00859032007170 ()


  • Radiation therapy software

Panther TPS - 00859032007132

No Description
Prowess, Inc.
5.7
In Commercial Distribution

  • 00859032007132 ()


  • Radiation therapy software

Panther TPS - 00859032007064

No Description
Prowess, Inc.
v5.6
Not in Commercial Distribution

  • 00859032007064 ()


  • Radiation therapy software

Panther Brachy - 00859032007002

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

  • 00859032007002 ()


  • Radiation therapy software

TCL3 Motion Tracking System - 05745000363056

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363056 ()

  • Height: 700 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system

TCL3 Motion Tracking System - 05745000363032

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363032 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system

TCL3 Motion Tracking System - 05745000363025

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363025 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system

TCL3 Motion Tracking System - 05745000363001

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363001 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system

MUCheck® - 00860175002403

MUCheck® Independent Dose Calculation Software. MUCheck® Software. MUCheck® Software Suite. Oncology Data Systems, Inc.
Oncology Data Systems Inc
MUCheck®
In Commercial Distribution

  • 00860175002403 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006349

No Description
VARIAN MEDICAL SYSTEMS, INC.
18.1
In Commercial Distribution

  • 00855141006349 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006202

No Description
VARIAN MEDICAL SYSTEMS, INC.
18.0
In Commercial Distribution

  • 00855141006202 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006103

No Description
VARIAN MEDICAL SYSTEMS, INC.
17.0
In Commercial Distribution

  • 00855141006103 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006080

No Description
VARIAN MEDICAL SYSTEMS, INC.
16.1
In Commercial Distribution

  • 00855141006080 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006073

No Description
VARIAN MEDICAL SYSTEMS, INC.
16.0
In Commercial Distribution

  • 00855141006073 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006066

No Description
Varian Medical Systems Finland Oy
15.6
In Commercial Distribution

  • 00855141006066 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006059

No Description
Varian Medical Systems Finland Oy
15.5
In Commercial Distribution

  • 00855141006059 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006042

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1.1
In Commercial Distribution

  • 00855141006042 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006035

No Description
VARIAN MEDICAL SYSTEMS, INC.
13.6
In Commercial Distribution

  • 00855141006035 ()


  • Radiation therapy software

Eclipse Treatment Planning System for External Beam Radiation Therapy - 00855141006028

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1
In Commercial Distribution

  • 00855141006028 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006011

No Description
Varian Medical Systems Finland Oy
15.0
In Commercial Distribution

  • 00855141006011 ()


  • Radiation therapy software

Eclipse Treatment Planning System - 00855141006004

No Description
Varian Medical Systems Finland Oy
13.7
In Commercial Distribution

  • 00855141006004 ()


  • Radiation therapy software

.decimal Astroid Planning App 3.x - 00851147007120

The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software

Decimal3D - 00851147007113

3D Scanning and Digitizing Application for Electron Therapy Apertures
DECIMAL, INC.
N/A
In Commercial Distribution

  • 00851147007113 ()


  • Radiation therapy software

.decimal Astroid Dosimetry App - 00851147007076

The .decimal Astroid Dosimetry App device is used for planning and analysis of proton radiation therapy treatments.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007076 ()


  • Radiation therapy software
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