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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Advanced Visualization Workspace 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.
Advanced Visualization Workspace - 15
In Commercial Distribution

  • 00884838115613 ()
30000957522X

  • Radiology DICOM image processing application software
Advanced Visualization Workspace 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.
Advanced Visualization Workspace - 15
In Commercial Distribution

  • 00884838121553 ()
881120

  • Radiology DICOM image processing application software
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Inc.
RMD-WEB-I
Not in Commercial Distribution

  • B037RESMDWEB0 ()


  • Radiological PACS software
Modular Startex Arm Pads. (Startex fabric covered visco-elastic foam arm pads for extra comfort). Modular Armpads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth and width adjustable. Left and Right armrest configurations available. Optional wheelchair component for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0153-MAP-IS
In Commercial Distribution

  • 07540147002756 ()
MAP-IS

  • Wheelchair armrest
Individual Calf Pad Mount Assy for use with the LNX Power Center Mount Legrest (upper assy) or MINI LNX Power CM Legrest (upper assy). Mounting hardware included. Standard LNX Calf Pad Mount Assy includes Independent Calf Pads (x2). Calf Pads are not included (purchased separately) with the MINI LNX Calf Pad Mount Assy.
Motion Concepts Inc
D-0101-0157-ICPM
In Commercial Distribution

  • 07540147002879 ()
ICPM

  • Wheelchair footrest/legrest
Gel Arm Pads. (Fabric covered polymer gel arm pads provide extra protection for highly sensitive arms). Available in 3 models: Standard Narrow: 2" x 12"; Standard Wide: 3.5" x 12"; and Long Wide: 3.5" x 14". Mounting hardware included. Depth adjustable. Optional wheelchair component for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0153-GAP
In Commercial Distribution

  • 07540147002732 ()
GAP

  • Wheelchair armrest
Multi Position Flat Arm Pads (Highly durable skinned polyurethane resists cracking and peeling and provides extra comfort and protection for arms) Flat Arm Pads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth and width adjustable Optional wheelchair component for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0153-MPA
In Commercial Distribution

  • 07540147002688 ()
MPA

  • Wheelchair armrest
A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. Hardware reference: Lenovo Thinkcentre M70a
KOELIS
KURO-4000
In Commercial Distribution

  • 03665134000929 ()


  • Image segmentation application software
The Micromed BRAIN QUICK system is an integrated acquisition system for physiological signals such as EEG and/or polysomnography (PSG) . The system includes hardware recorders, intended to acquire and temporarily store physiological signals for EEG and/or PSG, and software which is used for the signal acquisition, display, storage, process and measure of biologic signals.
MICROMED SPA
BRAIN QUICK
In Commercial Distribution

  • 08033928120910 ()


  • Electroencephalograph
The JAY® J3® wheelchair back product line offers a multitude of width, height, and contour depth back shells to fit the back to the client. Each back is lightweight and adjustable, with numerous hardware choices allowing for easy installation. The most popular 6" contour back, PD, is now available in over 40 sizes
SUNRISE MEDICAL (US) LLC
J3
In Commercial Distribution

  • 00016958052435 ()
E2613

  • Wheelchair seat cushion
Expression MRI Patient Vital Signs Monitor (Model MR200). Wireless ECG, Wireless Pulse Oximetry (SpO2),Non-Invasive Blood Pressure (NIBP), Integrated End-Tidal CO2, Advanced ECG Filters, Trend Arrows, All parameters support Adult, Pediatric, Infant and Neonatal applications,8-Hour Smart Battery Technology, Gauss Detection Alarm. One (1) day on-site Expression system training. One (1) year limited warranty and factory service for hardware
Philips Ds North America LLC
MR200 MRI Patient Monitoring System
In Commercial Distribution

  • 00884838033764 ()
866120

  • General-purpose multi-parameter bedside monitor
StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis.
NUCLEUSHEALTH, LLC
1000
In Commercial Distribution

  • 00860257001102 ()


  • Diagnostic imaging telemedicine system
Wall Mount Rack for Patient Slider Boards. Constructed of stainless steel material for ease of cleaning and prevention of infection spread. Hook holds small or large size patient transfer slider boards. Keeps boards clean and out of the way, yet in the spot you need them. Each rack holds one board. Mounting hardware not included due to varying substrates.
MID CENTRAL MEDICAL CORP.
MCM120-S
In Commercial Distribution

  • 10810030863462 ()

  • Length: 6 Inch
  • Height: 2 Inch
  • Depth: 2 Inch
MCM120-S

  • Patient position turntable
Wall Rack for EZ-Tranz Gold™ Patient Transfer Board. Constructed of stainless steel material for ease of cleaning and prevention of infection spread. Fits all sizes of EZ-Tranz Gold transfer boards. Keeps boards clean and out of the way, yet in the spot you need them. Each rack holds one board. Mounting hardware not included due to varying substrates.
MID CENTRAL MEDICAL CORP.
MCM199
In Commercial Distribution

  • 10810030860157 ()

  • Length: 6 Inch
  • Width: 1.625 Inch
  • Depth: 2.125 Inch
MCM199

  • Patient position turntable
Wall Rack for Patient Slider Boards. Constructed of stainless steel material for ease of cleaning and prevention of infection spread. Hook holds small or large size patient transfer slider boards. Keeps boards clean and out of the way, yet in the spot you need them. Each rack holds one board. Mounting hardware not included due to varying substrates.
MID CENTRAL MEDICAL CORP.
MCM120
In Commercial Distribution

  • 10810030860010 ()

  • Length: 18 Inch
  • Height: 2.75 Inch
  • Depth: 3 Inch
MCM120

  • Patient position turntable
Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear canal and measures the resulting otoacoustic emission that is generated by outer hair cells in the cochlea. The system collects and averages data samples until specified measurement parameters are achieved.
NATUS MEDICAL INCORPORATED
580-SPBOX1001
In Commercial Distribution

  • 00382830055031 ()
580-SPBOX1001

  • Evoked-potential audiometer
Modular Arm Pads (Highly durable skinned polyurethane resists cracking and peeling and provides extra comfort and protection for arms) Modular I-Skin Armpads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth and width adjustable. Left and Right armrest configurations available. Optional wheelchair component for use with Motion Concepts power positioning systems.
Motion Concepts Inc
D-0153-MAP-IS
In Commercial Distribution

  • 07540147002749 ()
MAP-IS

  • Wheelchair armrest
Ergonomic Arm Trough and Hand Pad Kit (Kit includes molded, skinned polyurethane arm trough designed to fit the natural arm curvature, together with a skinned polyurethane flat hand pad). Left and Right Kit configurations available.. Mounting hardware included. Depth and width adjustable. (The Flat Hand Pad and Arm Ergonomic Arm Trough are also available (sold) separately).
Motion Concepts Inc
D-0153-EAH
In Commercial Distribution

  • 07540147002725 ()
EAH

  • Wheelchair armrest
Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control,image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module), DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.
VISARIS DOO
Avanse DR
In Commercial Distribution

  • 08606102809033 ()


  • Radiological PACS software
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
Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016
Imagen Technologies, Inc.
1.0.0
In Commercial Distribution

  • 00852491008023 ()


  • X-ray image interpretive software
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
4.1.2.11
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
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