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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Quad-Link Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Quad-Link Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-SAQ
In Commercial Distribution

  • 07540147001995 ()
SAQ

  • Wheelchair bracket/mount
The Halcyon Couch Positioning Plate is an accessory to the 3D SCANNER system that allows the 3D SCANNER Water Tank to be placed and positioned on a Varian Halcyon delivery system couch. The Couch Positioning Plate is indexed to the Halcyon couch and coordinate system; SNC Dosimetry software Autosetup™ has been modified for Halcyon couch measurements using a new, patent-pending leveling technique.
SUN NUCLEAR CORP.
1231410Z
In Commercial Distribution

  • 05060608880201 ()
1231410Z

  • Accelerator system quality assurance device
V3D-Vascular is a software application used with advanced PC hardware for evaluating scanned images of selected vessels. It is designed to aid the physician in analyzing the vascular system based on DICOM 3.0 compliant images from CT or MR scan.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209VA2X00 ()


  • Radiological PACS software
Maxx Resolve Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Resolve Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests
Motion Concepts Inc
D-0181-MR
In Commercial Distribution

  • 07540147001988 ()
MR

  • Wheelchair bracket/mount
PowerDR Console Application is an X-ray digital imaging system designed for generating high-resolution, full-fidelity digital projection radiographic and fluoroscopic images with an X-ray imaging receptor. The PowerDR Console Application receives imaging exam orders, acquires images from X-Ray detectors or from any DICOM device to process the images to produce real time fluoroscopic image sequences and full fidelity radiographic images for medical diagnostic purposes. The processed and/or received images can be stored in a local or web/cloud based Picture Archive and Communication System (PACS).
Radiology Information Systems, Inc.
PowerDR
In Commercial Distribution

  • 00860009490604 ()


  • Radiology information system application software
  • Diagnostic x-ray digital imaging system workstation
  • Radiology picture archiving and communication system workstation
The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system.
SUN NUCLEAR CORP.
1231405Z
In Commercial Distribution

  • 05060608880195 ()
1231405Z

  • Accelerator system quality assurance device
The J3 Back now offers a Carbon Fiber shell option for the ultimate in lightweight performance. Weighing as little as 2.2 lbs. when combined with RH hardware, the J3 Carbon Fiber Back is the perfect addition to any Quickie ultra lightweight wheelchair.
SUNRISE MEDICAL (US) LLC
J3 Carbon Back
In Commercial Distribution

  • 00016958056785 ()
Jay

  • Gel-filled chair cushion
Matrx Back Interface Kit includes mounting hardware to affix a Matrx Elite, PB or E2 Back onto a Motion Concepts Power Positioning System with Tilt canes. Must specify the type of Matrx back being installed (Interface kits vary slightly depending on Back model).
Motion Concepts Inc
D-0139-MBIT
In Commercial Distribution

  • 07540147002916 ()
MBIT

  • Wheelchair bracket/mount
  • Wheelchair back rest positioner
Standard Arm Pads (Faux-vinyl cover PU foam arm pads for comfort and durability). Standard 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-SAP
In Commercial Distribution

  • 07540147002763 ()
SAP

  • Wheelchair armrest
Ergonomic Arm Trough (Molded, skinned polyurethane arm pad designed to fit the natural arm curvature; elbow cut-out allows for various arm positions) Left and right arm trough configurations available.. Mounting hardware included. Depth and width adjustable. Optional Flat Hand Pad available (sold separately).
Motion Concepts Inc
D-0153-EAT
In Commercial Distribution

  • 07540147002701 ()
EAT

  • Wheelchair armrest
The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC Version 8
Not in Commercial Distribution

  • 00724995163723 ()
XQSLC1

  • Operating room audiovisual data/device management system application software
Optional Bariatric Pivoting Calf Panel Assembly for use with the LNX Power Center Mount Legrest (upper assy) or the Compact Power Down LNX CM Legrest. Includes mounting hardware. Padded Calf Panel sold separately. Optional wheelchair component designed for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0101-LNXPCP
In Commercial Distribution

  • 07540147002886 ()
LNXPCP

  • Wheelchair footrest/legrest
Vitals360 Multi-Vitals Mobile Monitor VC-001
Vocare, Inc.
VC-001
In Commercial Distribution

  • 10860007323406 ()
  • 00860007323409 ()
  • 20860007323403 ()
  • 30860007323400 ()


  • Pulse oximeter
  • Infrared patient thermometer, skin
  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
  • Multiple vital physiological parameter monitoring system, clinical
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.9.9061
In Commercial Distribution

  • B359PSRISPACS6PRU9GA0 ()


  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.9.9110
In Commercial Distribution

  • B359PSRISPACS6PRU910 ()


  • 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
6.0.9.9060
In Commercial Distribution

  • B359PSRISPACS6PRU90 ()


  • 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
6.0.8.8111
In Commercial Distribution

  • B359PSRISPACS6PRU80 ()


  • Radiology information system
  • Radiology information system application software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359PSRISPACS6PRU720 ()


  • Radiology information system application software
  • Radiology information system
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer RIS/PACS 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359PSRISPACS6PRU70 ()
PSRISPACS6PRU7

  • Radiology information system application software
  • Radiology information system
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer RISPACS 6
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359PSRISPACS6PRU60 ()


  • 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
6.0.5.5100
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
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
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
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
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
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
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
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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