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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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Persyst Mobile App - 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software

Persyst Mobile App - 00869732000135

The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software

Persyst 14 Review and Analysis Software - 00869732000128

Persyst 14 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P14
In Commercial Distribution

  • 00869732000128 ()


  • Bioelectrical signal analysis software

Persyst 13 EEG Review and Analysis Software - 00869732000111

Persyst 13 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P13
In Commercial Distribution

  • 00869732000111 ()


  • Bioelectrical signal analysis software

Persyst 12 EEG Review and Analysis Software - 00869732000104

Persyst 12 EEG Review and Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.
Persyst Development Corp
P12
In Commercial Distribution

  • 00869732000104 ()


  • Bioelectrical signal analysis software

Natus - 00382830058575

IP Alarm Relay Box accessory kit
XLTEK
024006
In Commercial Distribution

  • 00382830058575 ()


  • Electroencephalograph

Natus - 00382830058216

Patient Room Alarm Relay Box (IP Version)
XLTEK
023019
In Commercial Distribution

  • 00382830058216 ()


  • Electroencephalograph

Natus - 00382830058209

IP Alarm Controller, Box
XLTEK
022979
In Commercial Distribution

  • 00382830058209 ()


  • Electroencephalograph

encevis - 09120109830122

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.12
In Commercial Distribution

  • 09120109830122 ()


  • Bioelectrical signal analysis software

encevis - 09120109830078

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
AIT Austrian Institute of Technology GmbH
1.6
In Commercial Distribution

  • 09120109830078 ()


  • Bioelectrical signal analysis software

NA - 00840682104272

No Description
GE Healthcare Finland Oy
E-ENTROPY-01
In Commercial Distribution

  • 00840682104272 ()


  • Patient monitoring system module, electroencephalographic

OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

Radixact®, Treatment Delivery Console (TDC) - M65810565930

Software, Version 1.0.0.3, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1056593
In Commercial Distribution

  • M65810565930 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console - M65810554870

Software, Version 1.0.0.2, Treatment Delivery Console, Radixact Version 1.0.0.2 (Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1055487
In Commercial Distribution

  • M65810554870 ()
NA

  • Linear accelerator system

Radixact®, Treatment Delivery Console (TDC) - M65810502410

Software, Version 1.0.0.1, Treatment Delivery Console (TDC), Radixact (Operating Software for Radixact® Treatment Delivery System)
ACCURAY INCORPORATED
1050241
In Commercial Distribution

  • M65810502410 ()
NA

  • Linear accelerator system

Widex - 05706069659788

Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Widex A/S
B-F2
In Commercial Distribution

  • 05706069659788 ()
8 393 0101 112

  • Hearing aid remote control application software

Automated Wound Measurements - 00860475000383

No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution

  • 00860475000383 ()


  • Wound management image-analysis software

SynGen® DataTrak - B039SGI07770

The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance.
Thermogenesis Corp.
SGI-0777
In Commercial Distribution

  • B039SGI07770 ()


  • Blood centrifugation system application software

Minuteful for Wound at Home - 17290017272877

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272716

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272716 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272709

The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272709 ()


  • Wound management image-analysis software

SPOT - 17290017272556

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.G25
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272556 ()


  • Wound management image-analysis software

SPOT - 17290017272501

The SPOT device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
SPOT.EN.GEN
In Commercial Distribution

  • 17290017272501 ()
  • 07290017272504 ()


  • Wound management image-analysis software

Brainlab Elements Fibertracking - 04056481142186

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion - 04056481140816

No Description
Brainlab AG
4.0
In Commercial Distribution

  • 04056481140816 ()


  • Radiological PACS software
  • Stereotactic system application software

Brainlab Elements Image Fusion Angio - 04056481138530

No Description
Brainlab AG
1.0
In Commercial Distribution

  • 04056481138530 ()


  • Radiological PACS software
  • Stereotactic system application software

Rapid - B761R610

Rapid System Update
Ischemaview, Inc.
6.1.0
In Commercial Distribution

  • B761R610 ()


  • Radiological PACS software

Rapid - B761R60

Rapid Platform plus cleared indications for Rapid version 6.x
Ischemaview, Inc.
6.x
In Commercial Distribution

  • B761R60 ()


  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

NA - 06944413808126

No Description
Edan Instruments, Inc.
Smart ECG Broker
In Commercial Distribution

  • 6944413808324 ()
  • 06944413808126 ()


  • Electrocardiograph, professional, multichannel

NA - 06944413808072

No Description
Edan Instruments, Inc.
Insight
In Commercial Distribution

  • 06944413808072 ()


  • Electrocardiograph, professional, multichannel

NA - 06944413807709

No Description
Edan Instruments, Inc.
Oximeter Viewer
In Commercial Distribution

  • 06944413807709 ()


  • Electrocardiograph, professional, multichannel

NA - 06944413807693

No Description
Edan Instruments, Inc.
Smart ECG Viewer
In Commercial Distribution

  • 06944413807693 ()
  • 06944413808065 ()


  • Electrocardiograph, professional, multichannel

ClearRead Xray Pneumothorax - M722XD25114P250640

ClearRead Xray Docker Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XD25114P250640 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722XD25064P250640

ClearRead Xray Docker Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XD25064P250640 ()


  • Radiological PACS software

ClearRead Xray | Pneumothorax - M722XD24079P212210

ClearRead Xray Pneumothorax on Docker Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XD24079P212210 ()


  • Radiological PACS software

ClearRead Xray | Pneumothorax - M722XD22145P212210

ClearRead Xray Pneumothorax on Docker Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution

  • M722XD22145P212210 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722XC25114P250640

ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25114P250640 ()


  • Radiological PACS software

ClearRead Xray Pneumothorax - M722XC25064P250640

ClearRead Xray Console Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution

  • M722XC25064P250640 ()


  • Radiological PACS software
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