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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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RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution

  • B359PSRISPACS6PRU510 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
  • Radiology information system application software
  • Radiology information system
A dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSRISPACS6PRU11B0 ()
PSRISPACS6PRU11B

  • Radiological PACS software
  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSRISPACS6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
  • Radiology information system application software
  • Radiology information system
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359PSRISPACS6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
  • Radiology information system application software
  • Radiology information system
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.5.5040
In Commercial Distribution

  • B359PSRISPACS60 ()
PSRISPACS6

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
  • Radiology information system application software
  • Radiology information system
PS RISPACS
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution

  • B359PSRISPACS0 ()
PSRISPACS6

  • Radiological PACS software
  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer. PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution

  • B359PSPACS0 ()
PSPACS6

  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
Matrx Back Recline Interface Kit (includes mounting hardware to affix a Matrx Elite, PB, E2 standard, E2 Mini, and Mini Back onto a Motion Concepts Power Positioning System with Recline canes. Must specify the type of Matrx back being installed (Interface kits vary depending on Back model).
Motion Concepts Inc
D-0139-MBIR
In Commercial Distribution

  • 07540147002923 ()
MBIR

  • Wheelchair bracket/mount
  • Wheelchair back rest positioner
Xcelera MR/CT Viewer is an image processing workstation software package designed to run on standard PC hardware. The ViewForum software receives image files from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication and printing and quantification of images.
Philips Medical Systems Nederland B.V.
6.1
In Commercial Distribution

  • 00884838070660 ()


  • Radiology picture archiving and communication system workstation
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
IntelliSpace Portal - 12
Not in Commercial Distribution

  • 00884838093621 ()
30001351160X

  • Radiology DICOM image processing application software
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
IntelliSpace Portal - 11
Not in Commercial Distribution

  • 00884838089808 ()
45980148092X

  • Radiology DICOM image processing application software
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
IntelliSpace Portal - 10
Not in Commercial Distribution

  • 00884838086449 ()
45980131596X

  • Radiology DICOM image processing application software
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
9.x
Not in Commercial Distribution

  • 00884838075894 ()


  • Radiology DICOM image processing application software
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution

  • 00884838073876 ()


  • Radiology DICOM image processing application software
Verity XR EnGauge Physical Rehabilitation System is an Extended Reality software platform that augments physical rehabilitation through exercise gamification incorporating biofeedback, kinematic data reporting, and immersive learning. The EnGauge Physical Rehabilitation System software readily integrates with existing Extended Reality hardware and peripherals to provide an integrated physical rehabilitation system.
Verity Technologies, Inc.
VXRE-01
In Commercial Distribution

  • 00860008232304 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Cross Brace Assembly for the MACES Back Interface is designed for use on Motion Concepts Power Positioning Systems configured with a Recline function. The MACES interface is limited to back widths ranging from 14W-20W. MACES hardware allows the for full rotational (multi-axis) angle adjustment of the mounted back support
Motion Concepts Inc
D-0139-MI
In Commercial Distribution

  • 07540147002961 ()
MI

  • Wheelchair bracket/mount
Waterfall Arm Pads (Highly durable skinned polyurethane resists cracking and peeling and provides extra comfort and protection for arms). Waterfall Arm Pads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth adjustable Optional wheelchair component for use with Motion Concepts power positioning systems
Motion Concepts Inc
D-0153-WAP
In Commercial Distribution

  • 07540147002695 ()
D-0153-WAP

  • Wheelchair armrest
Matrx Posture Back (PB) Heavy-Duty Back Support, (5" contour depth; 500lb weight capacity). HD mounting hardware included. Matrx Posture Backs are contoured to provide midline support and positioning. The wide variety of sizes and depths will provide exceptional comfort and support for a wide range of user needs.
Motion Concepts Inc
HDB
In Commercial Distribution

  • 07540147000042 ()
HDBwwhh

  • Wheelchair back rest
The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651911 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel
The HindexRV® Monitoring System is a physiological monitoring device that collects and transmits measurements (heart rate, respiration rate and muscle activity) using sensors. The HindexRV® monitoring system monitors the sympathetic and parasympathetic nervous system using accurate recordings of heart rate (HR) from EKG and provides statistical data as well as heart rate variability (HRV) data.
HHS SYSTEMS, INC.
1
In Commercial Distribution

  • 00860001651904 ()
SA7525HHS

  • Multi-purpose invasive/noninvasive electrode kit
  • Psychophysiological biofeedback system
  • Electrocardiographic electrode, single-use
  • Electrocardiograph, professional, single-channel
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