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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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iQ-SYSTEM PACS - B403IQS130

iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.3
In Commercial Distribution

  • B403IQS130 ()


  • Radiology picture archiving and communication system digital archive device

iQ-SYSTEM PACS - B403IQS120

iQ-SYSTEM PACS is a software device for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.
IMAGE Information Systems Europe GmbH
1.2
In Commercial Distribution

  • B403IQS120 ()


  • Radiology picture archiving and communication system digital archive device

Visible Patient Suite - VPS1019

Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography images. The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi- Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc. It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc. It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling. The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.
VISIBLE PATIENT
1.0.19
In Commercial Distribution

  • VPS1019 ()


  • Radiology picture archiving and communication system digital archive device

GoCheck Kids - B430GCKNOK44600

GoCheck Kids stand-alone software version 4.4.60 for the Nokia device.
Gobiquity, Inc.
Nokia 4.4.60
In Commercial Distribution

GCKNOK

  • External ocular measurement camera

QUASAR - G34310010185000

MRID 3D (5mm) Image Distortion Analysis System - Phantom and Software
Modus Medical Devices Inc
100-1018-500
In Commercial Distribution

  • G34310010185000 ()


  • Multi-modality therapeutic radiation phantom, test object

UbiqVue - B353UA2550C1

Active Monitoring Portal
Lifesignals, Inc.
UA2550-C
In Commercial Distribution

  • B353UA2550C1 ()


  • Wireless patient monitor/sensor reporting software, professional-only
  • Wearable multiple vital physiological parameter monitor

Accuray Precision® Treatment Planning System - M65810598110

Software, Version 1.1.1, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system

Accuray Precision® Treatment Planning System - M65810550960

Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution

  • M65810550960 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810502420

Software, Version 1.0, Precision Treatment Planning System The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
ACCURAY INCORPORATED
1050242
In Commercial Distribution

  • M65810502420 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer

Accuray Precision® Treatment Planning System - M65810642700

Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1064270
In Commercial Distribution

  • M65810642700 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
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