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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
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
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 AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.
NATUS MEDICAL INCORPORATED
AuDX Pro
In Commercial Distribution
- 00382830001595 ()
580-AXPRO1
- Evoked-potential audiometer
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- 00198168357521 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis