Singapore - English - HSA (Health Sciences Authority)

transmedic pte ltd - radiology / imaging - the uexplorer pet/ct is a diagnostic imaging system that combines two existing imaging modalities - pet and ct. the quantitative distribution information of pet radiopharmaceuticals within the patient body measured by pet can assist healthcare providers in assessing the metabolic and physiological functions. ct provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. the accurate registration and fusion of pet and ct images provides anatomical reference for the findings in the pet images. this system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Singapore - English - HSA (Health Sciences Authority)

transmedic pte ltd - radiology / imaging - the umi pet/ct is a diagnostic imaging system that combines two existing imaging modalities - pet and ct. the quantitative distribution information of pet radio pharmaceuticals within the patient body measured by pet can assist healthcare providers in assessing the metabolic and physiological functions. ct provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. the accurate registration and fusion of pet and ct images provides anatomical reference for the findings in the pet images. this system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Singapore - English - HSA (Health Sciences Authority)

fujifilm healthcare asia pacific pte ltd - radiology / imaging - be applied to examination in a wide clinical fields (abdominal, cardiac, intra-operative, fetal, pediatric, small organ, peripheral vessel, biopsy, trans-rectal,trans-vaginal, neonatal cephalic, adult cephalic, endoscopy, intra-luminal, gynecology,urology and laparoscopic) in combination with various kind of convex, linear and phased array high definition probes.

European Union - English - EMA (European Medicines Agency)

ge healthcare as - mangafodipir trisodium - magnetic resonance imaging - contrast media - this medicinal product is for diagnostic use only.contrast medium for diagnostic magnetic resonance imaging (mri) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. as an adjunct to mri to aid in the investigation of focal pancreatic lesions.

Singapore - English - HSA (Health Sciences Authority)

asia actual pte. ltd. - radiology / imaging - the upmr 790 system combines magnetic resonance diagnostic devices (mrdd) and positron emission tomography (pet) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. the combined system maintains independent functionality of the mr and pet devices, allowing for single modality mr and/or pet imaging. the mr is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. contrast agents may be used depending on the region of interest of the scan. the pet provides distribution information of pet radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. the combined system utilizes the mr for radiation-free attenuation correction maps for pet studies.

Australia - English - Department of Health (Therapeutic Goods Administration)

minimax implant pty ltd - 63669 - intraoral optical scanning system - a dental 3d scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. the system produces 3d scans for use in computer-assisted design and manufacturing of dental restorations.

Australia - English - Department of Health (Therapeutic Goods Administration)

race dental pty ltd - 63669 - intraoral optical scanning system - a dental 3d scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. the system produces 3d scans for use in computer-assisted design and manufacturing of dental restorations.

Australia - English - Department of Health (Therapeutic Goods Administration)

natus medical pty ltd - 63263 - auditory canal scanner - an electrically-powered device intended to collect data for the creation of three-dimensional (3-d) models of the auditory canal (outer ear). it consists of a short tube from insertion into the auditory canal, a display screen to assist operation of the device, and connections to a computing device for power and data transfer. it has no therapeutic nor diagnostic functions and may be used in a non-clinical setting by a trained professional.

Singapore - English - HSA (Health Sciences Authority)

bmec pte ltd - radiology / imaging - the scanner is a 2d and 3 d ultrasound echo and flow imaging system for diagnosis, data processing and transfer, guidance of puncture and biopsy.

Singapore - English - HSA (Health Sciences Authority)

canon medical systems asia pte., ltd. - radiology / imaging - the whole-body x-ray ct scanner aquilion is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities.