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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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Scale, SD-1150-WPBLE 1000LB Package (Scale, Handrail, Indicator, Pit Frame) 36IN(W)X 36IN(L) X 3IN(H) With Smooth Top Anti Slip Rubber Surface, Side Access Junction Box, 36IN(H)X 30IN(W) Steel Painted Handrail and Mounting Hardware. Indicator. 10FT Homerun Cable with Connector for Indicator. 36 in. x 36 in. Pit frame. Includes 6 AA size Alkaline batteries.
Rice Lake Weighing Systems, Inc.
SD-1150-WPBLE
In Commercial Distribution

  • 00850042373132 ()
205978

  • Wheelchair-accessible platform scale
Scale, SD-1150-WP 1000LB Package (Scale, Handrail, Indicator, Pit Frame) 36IN(W)X 36IN(L) X 3IN(H) With Smooth Top Anti Slip Rubber Surface, Side Access Junction Box, 36IN(H)X 30IN(W) Steel Painted Handrial And Mounting Hardware. Indicator. 10FT Homerun Cable With Connector For Indicator. 36 in. x 36 in. Pit frame. Includes 6 AA size Alkaline batteries.
Rice Lake Weighing Systems, Inc.
SD-1150-WP
In Commercial Distribution

  • 00850042373125 ()
150707

  • Wheelchair-accessible platform scale
V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan.
VIATRONIX INCORPORATED
1.1
In Commercial Distribution

  • B209CAR1X10 ()


  • Radiological PACS software
Push-button pelvic lap belt for use on Motion Concepts UL Maxx wheelchair seating systems equipped with Ultra-Rails. Lap belts are available in 4 sizes (lengths): 35", 48", 60" and 71". (Mounting hardware is included). IMPORTANT: Pelvic lap belts are provided for postural support only and are NOT suitable for use as vehicle safety belt during occupied transport in a wheelchair.
Motion Concepts Inc
D-0178-BELT
In Commercial Distribution

  • 07540147002992 ()
BELT

  • Wheelchair/chair/stander occupant restraint/support
Remidio FOP application along with FOP NM-10 hardware is intended for use in capturing & storing images of the retina and surrounding area of eye, with or without the use of Mydriatic agent and presenting the data to clinicians for evaluation or diagnosis. Light from the device is shown into the patient eye & the camera of a smartphone is used to capture images of the eye.
REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Remidio FOP
In Commercial Distribution

  • 08906096520052 ()


  • Ophthalmic image analysis software
The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution

  • 00860457001568 ()


  • Cardiac mapping system computer
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
4.1.2.33
In Commercial Distribution

  • B209VC4X1X2X330 ()


  • Radiological PACS software
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
4.1.2.32
In Commercial Distribution

  • B209VC4X1X2X320 ()


  • Radiological PACS software
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
4.1.2.11
In Commercial Distribution

  • B209VC4X1X2X110 ()


  • Radiological PACS software
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
4.1.1.15
In Commercial Distribution

  • B209VC4X1X1X150 ()


  • Radiological PACS software
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 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 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 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 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
Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system
Nordicneurolab AS
SIU 2.0
In Commercial Distribution

  • 07090042055024 ()


  • Medical networking interface unit
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 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 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
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
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