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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-Colon - B209VC4X0X3X40

V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.3.4
In Commercial Distribution

  • B209VC4X0X3X40 ()


  • Radiological PACS software

V3D-Colon - B209VC4X0X3X13F0

V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.3.13
In Commercial Distribution

  • B209VC4X0X3X13F0 ()


  • Radiological PACS software

V3D-Colon - B209VC4X0X0X44F0

V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.0.44
In Commercial Distribution

  • B209VC4X0X0X44F0 ()


  • Radiological PACS software

V3D-Colon - B209VC4X0X0X360

V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
4.0.0.36
In Commercial Distribution

  • B209VC4X0X0X360 ()


  • Radiological PACS software

V3D-Colon - B209VC3X3X3X10

V3D-Colon is a software application used with advanced PC hardware for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT scan, for the purpose of patient screening for detection of colon cancers, polyps, masses and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon.
VIATRONIX INCORPORATED
3.3.3.1
In Commercial Distribution

  • B209VC3X3X3X10 ()


  • Radiological PACS software

Essential MRI Patient Monitor (Model 865353) - 00884838012585

Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI environment. Key Features include: Communicates wirelessly with Invivo. Expression or Precess 2nd-Gen wSpO2 Modules for seamless patient transitions, Touch Screen Display Unrestricted MRI Gauss Rating, Lightweight portable Alarm light All parameters support Adult, Pediatric, infant and Neonatal applications,8-Hour Smart Battery Technology, Environmentally friendly Green, Flexible mounting options. One (1) year limited warranty and factory service for hardware
Philips Ds North America LLC
Essential MRI Patient Monitor
Not in Commercial Distribution

  • 00884838012585 ()
865353

  • Pulse oximeter

V3D-Explorer - B209XP2X00

V3D-Explorer is a software application used with advanced PC hardware for the display and 3D visualization of DICOM 3.0 compliant medical images derived from CT, MRI, PET and SPECT scans. The linear, angular and volume measurement features provided in the software for the evaluation and quantification of organ, hard and soft tissues as well as internal organ structures for lesion, mass and other anomalies. It also supports interactive segmentation of any organ.
VIATRONIX INCORPORATED
2.0
In Commercial Distribution

  • B209XP2X00 ()


  • Radiological PACS software

Fusion Bx - 00628055858003

Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer. Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate.
Focal Healthcare Inc
1.1
In Commercial Distribution

  • 00628055858003 ()


  • Radiology picture archiving and communication system workstation

True 3D Viewer - 00851325007003

Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
ECHOPIXEL, INC.
EP-00003
In Commercial Distribution

  • 00851325007003 ()
SW-0001-1601

  • Radiology picture archiving and communication system workstation
  • Radiology DICOM image processing application software

T.O.V.A. - 00862290000333

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software
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