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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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EnSite™ Courier™ - 05415067026187

Software Installation, 30 day trial, v.3.0
ST. JUDE MEDICAL, INC.
H702501-T
In Commercial Distribution

  • 05415067026187 ()
H702501-T

  • Cardiac mapping system application software

EnSite™ Courier™ - 05415067026170

Software Installation, v.3.0
ST. JUDE MEDICAL, INC.
H702501
In Commercial Distribution

  • 05415067026170 ()
H702501

  • Cardiac mapping system application software

EnSite™ - 05415067026163

Module, 30 day trial, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026163 ()
H702498-T

  • Cardiac mapping system application software

AutoMark - 05415067026149

Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software

EnSite™ - 05415067026132

Module, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026132 ()
H702498

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026125

Software Installation, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496
In Commercial Distribution

  • 05415067026125 ()
H702496

  • Cardiac mapping system application software

EnSite Precision™ - 05415067026118

Software Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software

EnSite™ Velocity™ - 05415067026101

Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software

MediGuide™ - 05415067024275

Cath Connect, Sensor Enabled
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067024275 ()
H702427

  • Cardiac mapping system application software

MediGuide™ - 05415067023841

System Installation Tool
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023841 ()
H702371

  • Cardiac mapping system application software

EnSite™ Velocity™ - 05415067023230

Utility Upgrade Kit
ST. JUDE MEDICAL, INC.
H702323
In Commercial Distribution

  • 05415067023230 ()
H702323

  • Cardiac mapping system application software

EnSite™ - 05415067005861

Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution

  • 05415067005861 ()
H700586

  • Cardiac mapping system application software

EnSite™ - 05415067003027

Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software

EnSite™ - 05415067002952

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution

  • 05415067002952 ()
H700295

  • Cardiac mapping system application software

EnSite™ - 05415067002938

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution

  • 05415067002938 ()
H700293

  • Cardiac mapping system application software

EnSite™ - 05415067002921

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution

  • 05415067002921 ()
H700292

  • Cardiac mapping system application software

EnSite™ - 05415067001863

Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution

  • 05415067001863 ()
H700186

  • Cardiac mapping system application software

EnSite™ - 05415067001856

Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software

EnSite™ - 05414734219211

Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software

Ensite™ - 05414734214841

No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software

Ensite™ - 05414734214636

No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software

JointVue jFit - 00850014885021

jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software

Hepatogram Plus - 00850011790199

No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software

MREplus - 00850011790014

No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software

MREplus - 00850011790007

No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software

Vave - 00850001977043

Software Application
Vave Health, Inc.
VUA
Not in Commercial Distribution

  • 00850001977043 ()
VUA

  • Ultrasound imaging system application software

suiteHEART - 00850001088015

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
5
In Commercial Distribution

  • 00850001088015 ()


  • MRI system application software

suiteHEART - 00850001088008

suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values.
NEOSOFT LLC
4.0.7
Not in Commercial Distribution

  • 00850001088008 ()


  • MRI system application software

See-Mode Technologies - 00860006305727

Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software

See-Mode Technologies - 00860006305703

Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software

MediScout system - 00860006066307

MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software

FIRMM® - 00860004785101

Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution

  • 00860004785101 ()

  • Length: 155 Millimeter
  • Width: 65 Millimeter
  • Height: 206 Millimeter
FIRMM®

  • MRI system application software

Caption AI (Caption Guidance + Caption Interpretation) - 00860003586303

The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC). The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution

  • 00860003586303 ()
511-00003

  • Ultrasound imaging system application software

Koios Medical - 00860002545707

The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software

NeuroQuant Brain Tumor - 00860000004824

No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution

  • 00860000004824 ()


  • MRI system application software

TrackX - 00850073646038

TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces.
TrackX Technology, LLC
TrackX Modular Malleting Adapter
In Commercial Distribution

  • 00850073646038 ()
TX-3-4369

  • Diagnostic x-ray digital imaging system workstation application software

UltraSPECT - 00850040177121

WBR Imaging X + X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177121 ()


  • SPECT system application software

UltraSPECT - 00850040177114

WBR Imaging X3 + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177114 ()


  • SPECT system application software

UltraSPECT - 00850040177107

WBR Imaging X + Bone/Xact + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177107 ()


  • SPECT system application software

UltraSPECT - 00850040177091

WBR Imaging X + X3 + ACSC
Ultraspect Usa, LLC
4.38.3.3
In Commercial Distribution

  • 00850040177091 ()


  • SPECT system application software
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