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

Show Filters

CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210296
In Commercial Distribution

  • 00852656007410 ()


  • Radiation therapy software
The Best TPS system is a computer based software system developed the use of assisting in the placement of anatomical localization and low dose rate isotope implants Best TPS uses multiple two-dimensional images including ultrasound and DICOM images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices.
Best Nomos
209867
In Commercial Distribution

  • 00852656007052 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210293
In Commercial Distribution

  • 00852656007045 ()


  • Radiation therapy software
CORVUS 09 is intended for use as a planning tool for conformal radiation therapy. CORVUS 09 is designed to generate plans for treatment delivery systems that can create multiple radiation patterns composed of pencil beams on which the intensity can be individually controlled. CORVUS 09 system is intended to be used as an integrated system with a modulating device for planning and delivery of conformal radiation therapy.
Best Nomos
210294
In Commercial Distribution

  • 00852656007038 ()


  • Radiation therapy software
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006060 ()


  • Vascular modelling software
A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
HL2 v6
In Commercial Distribution

CX-HL2-0001

  • Neuromuscular rehabilitation software
A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
ML2 v6
In Commercial Distribution

CX-ML2-0001

  • Neuromuscular rehabilitation software
A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
HL2
Not in Commercial Distribution

  • 05065012458046 ()
CX-HL2-0001

  • Neuromuscular rehabilitation software
A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
ML2
Not in Commercial Distribution

  • 05065012458039 ()
CX-ML2-0001

  • Neuromuscular rehabilitation software
IMPAX Volume Viewing and IMPAX PET & SPECT Viewing
Agfa HealthCare NV
4
In Commercial Distribution

  • 05400874001205 ()


  • Radiological PACS software
Enterprise Imaging XERO Viewer 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software
Enterprise Imaging Desktops 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software
SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts.
SUN NUCLEAR CORP.
1299028
In Commercial Distribution

  • 05060608880348 ()
1299000-0

  • Radiation therapy software
Blackford Registration Application v1.2.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830013 ()


  • Radiological PACS software
Blackford Platform v3.0.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
3.0.x
In Commercial Distribution

  • 05060570830150 ()


  • Radiological PACS software
Blackford Platform v2.4.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.4.x
In Commercial Distribution

  • 05060570830112 ()


  • Radiological PACS software
Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application, released under evaluation only.
BLACKFORD ANALYSIS LIMITED
1.4.x
In Commercial Distribution

  • 05060570830105 ()


  • Radiological PACS software
Blackford Platform v2.3.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.3.x
In Commercial Distribution

  • 05060570830099 ()


  • Radiological PACS software
Blackford Dashboard v1.2, monitoring tool for users of the Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.2.x
In Commercial Distribution

  • 05060570830082 ()


  • Radiological PACS software
Blackford Smart Localizer v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830075 ()


  • Radiological PACS software
Blackford Platform v2.2.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.2.x
In Commercial Distribution

  • 05060570830068 ()


  • Radiological PACS software
Blackford Registration Application v1.3.x, supplied with Blackford Platform (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
1.3.x
In Commercial Distribution

  • 05060570830044 ()


  • Radiological PACS software
Blackford Platform v2.1.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.1.x
In Commercial Distribution

  • 05060570830037 ()


  • Radiological PACS software
Blackford Platform v2.0.x, supplied with Blackford Registration Application (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.0.x
In Commercial Distribution

  • 05060570830006 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGW00001 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
W Version
In Commercial Distribution

  • D962GGAW0002 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGAR0003 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
SurgiCase Knee Planner
Materialise NV
SurgiCase Knee Planner
In Commercial Distribution

  • 05404028000922 ()
SurgiCase Knee Planner

  • CAD/CAM software
Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000908 ()
Mimics Flow

  • CAD/CAM software
Mimics Plugin RT Plugin
Materialise NV
RT Plugin
In Commercial Distribution

  • 05404028000892 ()
RT Plugin

  • CAD/CAM software
Mimics Plugin GRP Plugin
Materialise NV
GRP Plugin
In Commercial Distribution

  • 05404028000885 ()
GRP Plugin

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
Mimics Cardiac Planner
Materialise NV
Mimics Cardiac Planner
In Commercial Distribution

  • 05404028000762 ()
Mimics Cardiac Planner

  • CAD/CAM software
Mimics Automatic Algorithms Torso Bone CT
Materialise NV
Torso Bones CT
In Commercial Distribution

  • 05404028000731 ()
Torso Bones CT

  • CAD/CAM software
Mimics Automatic Algorithms Ankle CT
Materialise NV
Ankle CT
In Commercial Distribution

  • 05404028000724 ()
Ankle CT

  • CAD/CAM software
Mimics Medical
Materialise NV
Mimics Medical
In Commercial Distribution

  • 05404028000717 ()
Mimics Medical

  • CAD/CAM software
3-matic Medical
Materialise NV
3-matic Medical
In Commercial Distribution

  • 05404028000700 ()
3-matic Medical

  • CAD/CAM software
Mimics Plugin RT Plugin
Materialise NV
RT Plugin
In Commercial Distribution

  • 05404028000694 ()
RT Plugin

  • CAD/CAM software
Mimics Automatic Algorithms CMF CT
Materialise NV
CMF CT
In Commercial Distribution

  • 05404028000663 ()
CMF CT

  • CAD/CAM software
Mimics Flow
Materialise NV
Mimics Flow
In Commercial Distribution

  • 05404028000632 ()
Mimics Flow

  • CAD/CAM software
Mimics Cardiac Planner
Materialise NV
Mimics Cardiac Planner
Not in Commercial Distribution

  • 05404028000571 ()
Mimics Cardiac Planner

  • CAD/CAM software
Mimics Viewer XR
Materialise NV
Mimics Viewer XR
In Commercial Distribution

  • 05404028000496 ()
Mimics Viewer XR

  • CAD/CAM software
Mimics Automatic Algorithms Hip CT
Materialise NV
Hip CT
In Commercial Distribution

  • 05404028000380 ()
Hip CT

  • CAD/CAM software
Mimics Automatic Algorithms Shoulder CT
Materialise NV
Shoulder CT
In Commercial Distribution

  • 05404028000373 ()
Shoulder CT

  • CAD/CAM software
Mimics Automatic Algorithms CMF CBCT
Materialise NV
CMF CBCT
In Commercial Distribution

  • 05404028000366 ()
CMF CBCT

  • CAD/CAM software
Mimics Automatic Algorithms Knee CT
Materialise NV
Knee CT
In Commercial Distribution

  • 05404028000359 ()
Knee CT

  • CAD/CAM software
< 1 ... 55 56 57 58 59 ... 200 >