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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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V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.1
In Commercial Distribution

  • B209CAS2X10 ()


  • Radiological PACS software
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209CAS2X00 ()


  • Radiological PACS software
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
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
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
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
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
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