A component of a cardiac mapping system that is an adhesive device placed on the surface of a patient's body, typically the chest and/or back, to provide a fixed reference point for the tip of an internal, non-fluoroscopic catheter during an electrophysiolo...
A non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for im...
A non-sterile device in the form of a metal rod designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling of holes in the jawbone...
A non-sterile head covering designed as a cap intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative ...
A non-sterile device intended to be used with an electromagnetic device tracking system to provide a physician with an external fixed reference point on the patient's body for the electromagnetic (EM) tracking of instruments inside the patient using pre-acq...
A software program designed to be used in a healthcare setting to track the movements of an inpatient, typically a patient in a hospital side/isolation room or nursing home, to detect high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall r...
A non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and...
A non-powered, noninvasive component of a surgical navigation and/or tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable ...
A component of a surgical navigation and/or tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for o...
A non-powered, noninvasive component of a surgical navigation and/or tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable ...
A device intended to provide a reference signal to a pressure monitor (e.g., blood pressure monitor) for: 1) signal integrity/accuracy assessment; and/or 2) standardization of readings of physiological pressure signals [e.g., intracranial pressure (ICP), co...
A collection of non-sterile devices intended to assist collection of diagnostic magnetic resonance imaging (MRI) images to be used as part of radiation therapy treatment planning. It includes multiple devices intended to ensure adequate positioning and/or i...
A non-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure; the EM-tracking diagrams ...
A stationary assembly of computer-based devices designed to produce high-energy electrons to yield high-energy x-rays used to perform stereotactic radiosurgery (SRS) to treat brain, neck, or spinal cord tumours, and/or to perform stereotactic body radiation...
A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time...
A component of a surgical navigation and/or device tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope equipped with a tracking camera) intended to function as an optical reference to enable spatial track...
A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to ...
An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of p...
A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.
An electrically-powered device designed to be used in a healthcare or assisted living setting to track the movements of an inpatient/resident for capture of high-risk behaviour (e.g., bedridden patient bed vacation attempt, fall risk) and to automatically s...
An electrically-powered, noninvasive component of an electromagnetic surgical tracking system intended to provide a reference point for the electromagnetic (EM) tracking of an instrument and/or patient during a surgically-invasive procedure; the EM-tracking...
A noninvasive, electronic device intended to transcutaneously detect a patient's central venous pressure (CVP) using light emission/diffusion signals (e.g., near-infrared spectroscopy). It consists of a small photoelectric unit placed on the jugular vein ar...
An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clin...
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or v...