Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

acra regulatory services pty ltd - 63031 - cognitive function interactive software - active brain tracking is a computerized cognitive and functional brain performance assessment aid that provides clinicians with measurements of cognitive and functional brain performance in populations aged 12 to 65 years, to aid in the assessment of an individual's level of cognitive and functional brain performance. it relies on inputs from visual cues, auditory cues, and functional use of the hand. eq active brain tracking should only be used as an adjunctive tool for evaluating cognitive and functional brain performance and is not intended to be used for clinical decision assessment for specific diseases or conditions.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

corin australia pty ltd - 41669 - radiology picture archiving and communication system digital archive device - the radlink gps is a computer-based pacs that receives digital images (processed or raw/unprocessed) from various sources and displays them to the user for preliminary review. these sources include, but are not limited to, video signal inputs, wired or wireless transfer of image files from other acquisition systems (e.g. x-ray flat panel detector systems), or images transmitted to the radlink gps from other pacs systems. using the radlink gps, you can manipulate/post-process images, overlay lines/measurements/templates, store images, and transmit images to other pacs destinations.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 17898 - cardiac electrophysiology analysis system - this system is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. the system is configurable. clinical data includes: ecg waveforms, intracardiac signals, stimulus data, ablation data, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, and invasive and noninvasive blood pressure. physiological parameters such as diastolic, systolic, mean pressures, heart rate, and cycle length are derived from the signal data, displayed and recorded. the data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. procedural information and optional anatomical and physiological imaging and data devices may be interfaced [e.g. x-ray, ultrasound, mapping systems, ablation generators (e.g. rf and cryogenic)], stimulators, patient monitors and information systems. the system can display, store and annotate images previously acquired and stored by other systems. data may be provided to other systems via multiple formats (e.g. hl7, dicom, analog outputs). data may be received from other devices via multiple formats (e.g. dicom, analog inputs).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

ge healthcare australia pty ltd - 37807 - cardiac catheterization monitoring system - this device is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. the system is configurable. clinical data includes: ecg waveforms, heart rate, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, hemodynamic measures [e.g. valve gradients and areas, cardiac output, shunts, fractional flow reserve (ffr), invasive and noninvasive blood pressure] physiological parameters such as diastolic, systolic, mean pressures, and heart rate are derived from the signal data, displayed and recorded. the data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. procedural information and optional anatomical and physiological imaging and data devices may be interfaced (e.g. x-ray, ultrasound, patient monitors and information systems). the system can display, store and annotate images previously acquired and stored by other systems. data may be provided to other systems via multiple formats (e.g. hl7, dicom, analog outputs). data may be received from other devices via multiple formats (e.g. dicom, analog inputs).

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

eyetelligence pty ltd - 58713 - automated retinopathy analysis system application software - the eyetelligence system is intended to screen and grade diabetic retinopathy (dr), cataract, aged related macular degeneration (amd) and glaucoma in patients/consumers through retinal images. the eyetelligence system outcomes are intended to be subsequently verified and certified by a qualified medical/eye care professional who will make a clinical decision based on a range of inputs not limited to eyetelligence outcomes.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

xrhealth au pty ltd - 63031 - cognitive function interactive software - the vrcogni are a prescription only medical device software applications that provide various vr environments to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. the cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable: ? guiding patients in the performance of various cognitive exercises ? track and analyze motion and movement kinematics ? monitoring changes in patient's measurements over time the vrcogni ct-610 and ct-620 can be used as an assessment aid to determine the level of cognitive function for which there exists other valid methods of cognitive assessment. vrcogni ct-610 and ct-620 are not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. moreover, they do not identify the presence or absence of clinical diagnoses.

Malta - angličtina - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - disodium phosphate, dihydrate, magnesium chloride, hexahydrate, sodium chloride, sodium hydrogen, carbonate, potassium chloride - solution for haemofiltration solution for haemodialysis - disodium phosphate dihydrate 0.187 g/l magnesium chloride hexahydrate 3.05 g/l sodium chloride 7.01 g/l sodium hydrogen carbonate 2.12 g/l potassium chloride 0.314 g/l - blood substitutes and perfusion solutions

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - magnesium chloride hexahydrate; sodium chloride; sodium hydrogen carbonate; potassium chloride; disodium phosphate dihydrate - solution for haemodialysis/haemofiltration - hemofiltrates

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - calcium chloride dihydrate; magnesium chloride hexahydrate; sodium chloride ph.eur.; sodium hydrogen carbonate; potassium chloride; disodium phosphate dihydrate - solution for haemodialysis/haemofiltration - 1.2 mmol/l - hemofiltrates

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

eyetelligence pty ltd - 58713 - automated retinopathy analysis system application software - the eyetelligence microvascular health is a software as a service product this product intends to assess the retinal vascular system and screen for microvascular health issues of the body, based on full colour fundus photos that are generated from fundus camera. the eyetelligence system outcomes are intended to be subsequently verified and certified by a qualified medical/eye care professional who will make a clinical decision based on a range of inputs not limited to eyetelligence outcomes.