A software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical ...
A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introdu...
A non-powered, mechanical instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip and/or pinch strength in clinical or ...
A stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of...
An electrically-powered instrument designed to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It is used to assess a patient's grip strength in clinical or research settin...
A software program intended to display, analyse/process, and possibly acquire images of the teeth/gums, and typically surrounding region, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a dental condition. The images a...
An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization...
A software program intended to be used in a clinical setting to display and analyse/process images of the eye, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of an ophthalmic condition. The images are typically acquired ...
An analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a force gauge, which may be attached to a handle or strap, to assess a variety of moveme...
A portable, hand-held, electrically-powered, digital instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion. It includes a force gauge, which may be attached to a ha...
An application software program intended to analyse image data captured by an embryo-assessment microscope camera system to store, and allow comparison/evaluation of, acquired embryo images, to assist embryo selection during assisted reproduction/in vitro f...
A hand-held instrument designed to measure the maximum rate of oral or nasal inspiratory gas flow [peak inspiratory flow (PIF) or peak inspiratory flow rate (PIFR)] into the lungs, to assess airway patency. It is in the form of a cylinder with a mouthpiece ...
An assembly of non-sterile portable electronic devices designed to perform an integrity test on the implantable portion of a cochlear implant (CI) system in situ; the test is intended to provide objective data on implant function and aid in the assessment o...
A software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the chest anatomy (e.g., lungs, heart) and/or vascular system, to support a healthcare provider with clini...
An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumat...
A software program designed to be used on an off-the-shelf smart device with a built-in camera (e.g., smartphone, tablet) to allow a healthcare provider/caregiver to obtain images/video of a patient to assess the patient’s level of pain; it is typically use...
An application software program intended to be used by: 1) a healthcare professional (e.g., optician, optometrist, ophthalmologist) to analyse, manage, and create reports relating to images of the eye, captured by either a professional ophthalmic device (e....
An electronic instrument designed to measure and assess the electrical characteristics of a power line receptacle (e.g., an electrical wall receptacle or electrical wall socket). It is typically a plug-in device that can detect open (e.g., ground, live, neu...
An invasive device intended to assess the dimensions of a tracheostoma to help in the selection of an appropriately sized invasive tracheostomal appliance (e.g., laryngectomy tube). It is typically in the form of a shaped template designed to assess the int...
A non-powered, analogue instrument designed to assess neuromuscular function by measuring the force or power exerted by the back, chest, and leg muscles during flexion. It includes a mechanical force gauge, which may be attached to a handle or strap, to ass...
A software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the brain (includes intracranial vessels), to support a healthcare provider with clinical assessment (e.g....
A software program intended to display and analyse/process ultrasound images of the breast, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of breast cancer. It is not dedicated to treatment planning and does not incorpor...
An interpretive software program intended to be used in the assessment of risk/probability for having a cardiovascular condition (e.g., significant coronary stenosis) or event (e.g., heart attack, ischemic stroke, unstable angina, coronary revascularization...
An electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of potential brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking (e.g., infrared cameras)...
An in vitro diagnostic interpretive software program intended to be used in the assessment of risk of progression of chronic kidney disease (CKD). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in v...
A device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)...
An assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one pa...
A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG)...
A non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and a...
A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of ...