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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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SPiNPlanning Laptop Workstation - 00815686020033

No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-0185
Not in Commercial Distribution

  • 00815686020033 ()
SYS-0185

  • Virtual bronchoscopic navigation PACS software

NA - 00763000632793

SW APP A820 TDD PATIENT PROG V2.X
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00763000632793 ()


  • Infusion pump programmer

NA - 00763000632786

SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer

LungVision System - 07290017652085

The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures. The mobile system cart is an optional unit to place the LUNGVISIONTM Main Unit and router, also used for storing all the system components: LV Board, Tablet, DVD reader, Keyboard, Mouse and cables.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652085 ()
LV1055002

  • Virtual bronchoscopic navigation PACS software

LungVision System - 07290017652030

The LungVision System is designed to enable users to segment previously acquired 3D CT data sets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
BODY VISION MEDICAL LTD
Core
In Commercial Distribution

  • 07290017652030 ()
LV1055001

  • Virtual bronchoscopic navigation PACS software

SafeCT - 07290016836004

The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution

  • 07290016836004 ()


  • CT system application software

NA - 00763000875701

PRGM 8835 PERSONAL THRPY MG2 SRVC US
MEDTRONIC, INC.
8835-SVC
In Commercial Distribution

  • 00763000875701 ()


  • Infusion pump programmer

NA - 00763000875695

PRGM 8835 PERSONAL THRPY MG2 RFRB US
MEDTRONIC, INC.
8835-RFB
In Commercial Distribution

  • 00763000875695 ()


  • Infusion pump programmer

NobelClinician® - 07332747125177

NobelClinician 3.1 for MAC
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125177 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125160

NobelClinician 3.1 for Windows 64-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125160 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125153

NobelClinician 3.1 for Windows 32-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125153 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124972

NobelClinician 2.8 for Windows MAC
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124972 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124958

NobelClinician 2.8 for Windows 64-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124958 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124941

NobelClinician 2.8 for Windows 32-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124941 ()
101560

  • General-purpose dental x-ray system application software

CT LVAS - 19356870000021

CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
4DMEDICAL LIMITED
1.x
In Commercial Distribution

  • 19356870000021 ()


  • CT system application software

XV Lung Ventilation Analysis Software - 19356870000014

The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases. The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report. The key outputs are: • The tidal volume (i.e. total lung ventilation), presented as a single value; • Visualization of lung ventilation with color-defined specific ventilation ranges; • The heterogeneity of lung ventilation, presented as three values; and • Ventilation graph/ histogram of the classified lung voxel’s relative frequencies including ventilation defect percentage.
4DMEDICAL LIMITED
XV LVAS
In Commercial Distribution

  • 19356870000014 ()


  • CT system application software

ReJoyce - 17540176010002

The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities. The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games. The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life.
Rehabtronics Inc
RV10
In Commercial Distribution

  • 17540176010002 ()


  • Virtual-display arm rehabilitation system, non-gravity-compensating

AirView - 00840193400276

AirView
RESMED CORP.
22240
In Commercial Distribution

  • 00840193400276 ()
22240

  • Ventilator application software
  • Medical equipment clinical data interfacing software

Live View Panel Pro Version 2.0 - 00817111021264

Live View Panel Pro Version 2.0
Neurotronics, LLC
2.0
In Commercial Distribution

  • 00817111021264 ()


  • Sleep disorder interpretive software, professional-only
  • Bioelectrical signal analysis software

Live View Panel Version 1.4 - 00817111020816

Live View Panel Version 1.4
Neurotronics, LLC
1.4
In Commercial Distribution

  • 00817111020816 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only

Live View Panel Version 1.3 - 00817111020786

Live View Panel Version 1.3
Neurotronics, LLC
1.3
Not in Commercial Distribution

  • 00817111020786 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only

Norav 1200 Series PC-ECG - 07290110252755

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Nethasp Holter for additional work station, Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-N
In Commercial Distribution

  • 07290110252755 ()
HASP-SW-K-NH301-Net-1

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252731

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Network Solution for NH300 - No additional users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300-N
In Commercial Distribution

  • 07290110252731 ()
HASP-SW-KNH300-3N-M-02

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252717

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser

Norav 1200 Series PC-ECG - 07290110252557

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS-Q, SQL Base License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-Q1
In Commercial Distribution

  • 07290110252557 ()
HASP-SW-K-NEMS-Q-01

  • Patient-administration information system application software

Norav 1200 Series PC-ECG - 07290110252533

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Single User License The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-A1
In Commercial Distribution

  • 07290110252533 ()
HASP-SW-K-NEMS-A-01

  • Patient-administration information system application software

REMI - 00860005388172

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
1.x.x.x
Not in Commercial Distribution

  • 00860005388172 ()


  • Electroencephalographic monitoring system

EnSite™ - 05415067053145

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067051097

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

EnSite™ - 05415067048394

X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software

EnSite™ - 05415067048370

X EP System Averaged Impedance Drop Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-IMP-01
In Commercial Distribution

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software

EnSite™ - 05415067047861

X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

ABACUS - 05413765577369

ABACUS Order Entry & Calculation Software versions 3.3.x ME
BAXTER HEALTHCARE CORPORATION
83003393
In Commercial Distribution

  • 05413765577369 ()
83003393

  • Intravenous solution compounder

ABACUS - 05413765577352

ABACUS ORDER ENTRY & CALCULATION SOFTWARE VERSIONS 3.3.X SE
BAXTER HEALTHCARE CORPORATION
83003392
In Commercial Distribution

  • 05413765577352 ()
83003392

  • Intravenous solution compounder

ABACUS - 05413765577345

ABACUS Order Entry & Calculation Software versions 3.3.x CE
BAXTER HEALTHCARE CORPORATION
83003391
In Commercial Distribution

  • 05413765577345 ()
83003391

  • Intravenous solution compounder

ABACUS - 05413765577321

ABACUS Order Entry & Calculation Software versions 3.3.x DE
BAXTER HEALTHCARE CORPORATION
83003390
In Commercial Distribution

  • 05413765577321 ()
83003390

  • Intravenous solution compounder

EnSite™ - 05415067037770

X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software

EnSite™ - 05415067037749

X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software

HolterCare Editing Kit - 00856298006268

License dongle for second workstation using the HolterCare software.
SCOTTCARE CORPORATION, THE
HolterCare Editing Kit
In Commercial Distribution

  • 00856298006268 ()
100080

  • Electrocardiographic long-term ambulatory recording analyser application software

ACPlus Respiratory Assessment - 00858703006344

Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional

Eko Mobile App iOS - 00863609000334

iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software

REMI - 00860011072447

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072447 ()
20016

  • Electroencephalographic monitoring system

REMI - 00860011072416

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Startup Module
Epitel, Inc.
2.x.x.x
In Commercial Distribution

  • 00860011072416 ()
20016

  • Electroencephalographic monitoring system

LiDCO - 05060110523030

Licence, Software, LiDCOrapid (Rapid, CNAP, BIS, Ext), Six Month
LIDCO LIMITED
Li11076H
In Commercial Distribution

  • 05060110523030 ()
Li11076H

  • General-purpose multi-parameter bedside monitor

TrakStar Patient Data Management System Software - 00850005944553

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Cloud)
In Commercial Distribution

  • 00850005944553 ()
83-00090-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944447

Local version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.8 (Local)
In Commercial Distribution

  • 00850005944447 ()
83-00091-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944133

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.6 (Cloud)
In Commercial Distribution

  • 00850005944133 ()
83-00060-000

  • Magnetic neural stimulation system

TrakStar Patient Data Management System Software - 00850005944126

Cloud version of TrakStar Patient Data Management System Software
NEURONETICS, INC.
Version 7.5 (Cloud)
In Commercial Distribution

  • 00850005944126 ()
83-00060-000

  • Magnetic neural stimulation system
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