Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - cardiovascular - the shockwave intravascular lithotripsy (ivl) system with the shockwave c2 coronary ivl catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.”

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - neurology - this product is indicated to restore blood flow by removing thrombus from an intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. patients who are ineligible for iv t-pa or who fail iv t-pa therapy are candidates for treatment.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - radiology / imaging - it is a computer-assisted detection (cad) software device based on an artificial intelligence algorithm intended for use as a concurrent reading aid for interpreting physicians reading chest radiographs, to detect, localize, identify, and characterize suspicious abnormal radiological findings. as an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that considers other relevant information from the image or patient history. it analyzes chest radiographs using machine learning techniques to identify and characterize suspicious areas for abnormal radiologic findings the device identifies suspicious areas of abnormal radiologic findings including atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule, pneumothorax, pleural effusion and pneumoperitoneum on chest radiographs

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - radiology / imaging - lunit insight mmg is a computer-assisted detection/diagnosis (cad) software device based on an artificial intelligence algorithm intended to aid in the detection, localization, identification, and characterization of suspicious areas for breast cancer on mammograms. as an adjunctive tool, the device is intended to be viewed by interpreting physicians and it is not intended as a replacement for a complete clinician’s review or their clinical judgement that takes into account other relevant information from the image or patient history lunit insight mmg is intended for use in screening mammograms to identify and characterize suspicious areas for breast cancer for interpreting physicians’ review.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - physical medicine - iratherm®1000m is a whole-body hyperthermia system. it serves to raise the body core temperature up to about 40.5°c within the scope of mild and moderate whole-body hyperthermia. it is intended to relieve muscle fatigue, muscle stiffness and muscle pain.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - cardiovascular - the shockwave medical ivl system is intended for lithotripsy-enhanced balloon dilatation of moderate to severe calcified lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. not for use in the coronary or cerebral vasculature.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - general & plastic surgery - indication: it is indicated to be used for facial tissue augmentation for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - cardiovascular - the ivac is intended for use in patients with impaired left ventricular function which require left ventricular mechanical circulatory support for up to 24 hr. the ivac2l tip should be positioned in the left ventricular cavity through the femoral artery.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - radiology / imaging - art-plan offers the tools to aid in the workflow of radiotherapy treatment: multi-modal visualization and rigid- and deformable registration of anatomical and functional images. display of fused and non-fused images to facilitate the comparison and delineation of image data by the user. manual modification and semi-automatic generation of contours for the regions of interest. automatic generation of contours for organs at risk and healthy lymph nodes, based on medical practices, on medical images generation of pseudo-ct from mr images and cbct images for supported anatomies dose computation on ct images for external beam irradiation with photon beams evaluation of volumetric changes and dose coverage changes on daily images in comparison with the planned dose to evaluate a treatment during the treatment course. report standardized metrics to compare the delivered and planned doses that are based on the institution’s chosen standards to help identify the need for replanning.

Singapore - English - HSA (Health Sciences Authority)

qualtech consulting corporation pte. ltd. - radiology / imaging - the breast ct system uses radiography to produce tomograms of the mammary gland and the surrounding breast tissue to help with diagnosis. each breast is examined separately.