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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
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
4.0.3.13
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
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
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
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
SS Roller Board Rack is designed to hold patient transfer roller boards on the wall. This keeps the roller boards clean and off the floor, protects them from damage, and stores them at the point of use so they are always right where you need them, when you need them. Constructed of stainless steel with no seams or cavities makes them easy to clean and disinfect. Hardware is not included, due to varying substrates in medical facilities.
MID CENTRAL MEDICAL CORP.
MCM132
In Commercial Distribution
- 10810030860102 ()
- Length: 9 Inch
- Height: 2 Inch
- Depth: 1.75 Inch
MCM132
- Patient position turntable
The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value
NORAV MEDICAL LTD.
PCECG 1200W
In Commercial Distribution
- 07290110250485 ()
- Electrocardiography telemetric monitoring system transmitter
The Digi-Lite IP color flow imaging system is an ultrasound based system intended for use in non-invasive vascular evaluation for carotid (extracranial diagnosis), peripheral nerves and musculoskeletal in adults and in children. The Digi Lite IP only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Digi Lite IP via USB 2.0. Minimum requirements are given for the PC. The Linear probe is connected to the Digi Lite IP.
RIMED LTD.
Digi-Lite IP
In Commercial Distribution
- 07290016734010 ()
400001
- General-purpose ultrasound imaging system
TL-6800 Auto lensmeter
Hartmann sensor with 145 measurement points, ensures better result for progressive and multi-focus recognition and more accurate results
Green spectral measurement light source
Higher level hardware, good tracing performance of the optical system and faster measurement speed
Can measure lens of low transmittance rate no less than 5% , sun glasses with dark color, tinted lens and polarized lens
UV measurement
Humanized design, tiltable screen, comfortable operation and easier for observation
Data can be transferred to auto phoropter
Ningbo Ming Sing Optical R & D Co., Ltd.
TL-6800
In Commercial Distribution
- 06971821408020 ()
- Manually-adjusted lensmeter, line-powered
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.
Philips Medizin Systeme Böblingen GmbH
Expression MR400 MRI Patient Monitor Sys
In Commercial Distribution
- 00884838111363 ()
866185
- General-purpose multi-parameter bedside monitor
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.2
In Commercial Distribution
- 00884838093997 ()
45980163324X
- Radiology picture archiving and communication system workstation
illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. illumeo is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. illumeo integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
v2.x
In Commercial Distribution
- 00884838087958 ()
45980141116X
- Radiology picture archiving and communication system workstation
Expression Patient Monitor (MR400): 15 inch Widescreen Touchscreen interface, MRI Rating 5,000 gauss 4W/kg SAR 3.0T, 8-Hour Smart Battery Technology, 3rd-Gen Wireless ECG with Advanced Filters, 3rd-Gen Wireless Pulse Oximetry (SpO2) with Perfusion Index, Single-Lumen Non-Invasive Blood Pressure (NIBP), CO2 monitoring with Respiration Rate, Wired and wireless gating with MRI systems, and Multi-priority alarm system with CDS. All parameters support Adult, Pediatric, Infant and Neonatal applications. One (1) day on-site Expression system training, One (1) year limited warranty and factory service for hardware.
Philips Ds North America LLC
Expression MR400 MRI Patient Monitor Sys
Not in Commercial Distribution
- 00884838039131 ()
866185
- General-purpose multi-parameter bedside monitor
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using display monitors approved for digital mammography.
Philips Healthcare Informatics, Inc.
IntelliSpace Radiology - 4
In Commercial Distribution
- 00884838091740 ()
836344
- Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution
- 00884838074743 ()
- Radiology picture archiving and communication system workstation
CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.
Richard Wolf GmbH
5597101
In Commercial Distribution
- 04055207058848 ()
5597101
- Operating room audiovisual data/device management system application software
The Pathway Pain & Sensory Evaluation System is a computerized thermal stimulator designed for neurological and pain research. Pathway expands the functions offered by Medoc TSA-II, introducing new hardware and software capabilities to expand the quantitative investigation of human nociceptive pathways.
The PATHWAY is a pain management and pain research system intended to be used for the quantitative assessment of small nerve fiber dysfunctions. It measures sensory thresholds such as cold and warm sensation and heat-induced pain.
The Device includes: main unit, at least one probe/thermode and accessories.
MEDOC LTD.
Pathway
In Commercial Distribution
- 07290103039806 ()
- 07290103039301 ()
MO 00007-12
- Thermotester, diagnostic
SmarTooth is an optical dental caries diagnostic device that uses a laser to help diagnose dental caries. The SmarTooth comprises a portable hardware main body with batteries, a main body holder, and a mobile application. The hardware components provide a laser source, an LED indicator, and a zero point adjustment (calibration) unit to aid in detecting and monitoring dental caries lesions in teeth. The software component provides a meter with a digital readout between 0 and 99. The hardware device is a pen type device consisting of a laser diode that generates a laser and a photodiode sensor to detect fluorescent light. Both the sensor and laser diode are mounted at the tip of the device and introduced into the mouth of the patient for scanning of the teeth. The tooth is exposed to irradiation of a 650nm wavelength laser by this device, and a value from the detected fluorescent light is displayed to refer to the diagnosis of dental caries. The software handles the information from the scanner, which controls the user interface.
The subject device is designed for handheld operation as a battery-operated, portable laser source with a photodiode sensor. The dental probe is a replaceable, single use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The main body holder calibrates the device before measuring the teeth.The subject device is designed for handheld operation as a battery operated, portable laser source with a photodiode sensor. The dental probe is a replaceable, single use component made from ABS material. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures physical and optical contact with dentinal fluid at sites that are not readily accessible or eval
Smartooth Co., Ltd.
STL-02-BK
In Commercial Distribution
- 08809941490121 ()
- 08809941490008 ()
- Dental caries detector, optical induced fluorescence
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography.
Philips Medical Systems Nederland B.V.
Vue Motion - 12
In Commercial Distribution
- 00884838100367 ()
1017979
- Radiological PACS software
IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Philips Healthcare Informatics, Inc.
IntelliSpace PACS - 4
In Commercial Distribution
- 00884838074781 ()
837507
- Radiology picture archiving and communication system workstation
Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.
Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).
MERGE HEALTHCARE SOLUTIONS INC.
7.3
In Commercial Distribution
- 00842000100690 ()
- Radiology picture archiving and communication system workstation
The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
ICAT SOLUTIONS LTD
HOROS MOBILE
In Commercial Distribution
- 05070002336815 ()
- Radiology picture archiving and communication system workstation
IntelliSpace Radiology is a software package intended to be used by trained professionals, including
but not limited to physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing,
measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received
from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG,
SC, VL, and OP as well as hospital/radiology information systems.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to
Mammography. Lossy compressed mammographic images and digitized film/screen images must not
be reviewed for primary image interpretations.
Philips Medical Systems Nederland B.V.
IntelliSpace Radiology - 4
In Commercial Distribution
- 00884838123809 ()
836344
- Radiology picture archiving and communication system workstation
The eVox System is intended for the acquisition, display, and storage, of electrical activity
of a patient’s brain including electroencephalograph (EEG) and event-related potentials
(ERP) obtained by placing two or more electrodes on the head to aid in diagnosis
The medical system includes the “eVox System” amplifier device, accessories, and a
computer (laptop computer or tablet device with internal battery and power cord).
The hardware and ancillary components used in conjunction with the eVox System include
an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and
wall adapter), a Subject Response Device and a Base Station laptop computer. The
software on the Base Station laptop computer is intended for device functioning
EVOKE NEUROSCIENCE, INC.
EVO-002-400-000
In Commercial Distribution
- 00867606000304 ()
- Electroencephalograph