Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the logiq s7 expert/pro is intended for use by a qualified physician for ultrasound evaluation. specific clinical applications and exam types include: fetal/obstetrics, abdominal (includes renal, gyn/pelvic), pediatric, small organ (breast, testes, thyroid), neonatal cephalic, adult cephalic, cardiac (adult and pediatric), peripheral vascular, musculo-skeletal conventional and superficial, urology (including prostate), transrectal, transvaginal, intraoperative (abdominal, thoracic, vascular and neurosurgical).

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. pediatric population is defined as patients between the ages of 0 and 15 years. the mac1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ecg signals from surface electrodes. the mac1600 is used under the direct supervision of a licensed healthcare practitioner. the mac 1600 is not designed to provide alarms for arrhythmia detection. the device is not suitable for intra cardiac application. it is not intended for use as a vital signs physiological monitor or for use during patient transport.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 3500 ecg analysis system is intended to acquire, analyze, display and record testing electrocardiographic information from adult and pediatric populations. basic systems deliver 3,6,12 or 15 lead ecgs, including interpretive analysis. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 5500hd ecg analysis system is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. basic systems deliver 3, 6, 12, or 15 lead ecg’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of qrs and p wave portions of the electrocardiogram. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 5500hd is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 800 resting ecg analysis system is a portable ecg acquisition, analysis and recording system intended to: acquire, analyze, display, and record information from adult and pediatric populations; be used under the direct supervision of a licensed health care practitioner;be used by trained operators in a hospital or medical professional’s facility environment, as well as used in clinics, physician offices, outreach centers;offer two basic modes of operation: (1) resting ecg mode and (2) arrhythmia mode; print 3- and 6 leads of ecg; be upgradeable to provide software options such as 12-lead ecg measurement and interpretive analysis, provide for the optional transmission and reception of ecg data to and from a central ecg cardiovascular information system.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac-lab system is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. clinical data includes: ecg waveforms, heart rate, pulse oximetry (spo2), respiration rate, co2 (etco2), temperature, hemodynamic measures (for example, valve gradients and areas, cardiac output, shunts, fractional flow reserve (ffr), invasive and noninvasive blood pressure).

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - mac 1200 is an ecg acquisition and recording system with a built-in printer and graphics display. the intended use of this device is for data acquisition and recording for resting ecg and stress testing ecg and for recording ecg in real time with arrhythmia detection. it supports the operation modes:12 lead mode; 6 lead mode, arrhythmia mode. optionally it provides measurement and interpretation of the 10-second resting ecgs. it is intended to be used by trained operators under direct physician supervision when ecg records are required. it is suitable for intracardiac application. it is designed as a portable device.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge nm/ct 850 system is intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. it includes a general purpose nuclear medicine system using a variety of scanning modes supported by various acquisition types, and a computed tomography component which is intended specifically for enabling attenuation correction and anatomical localization of spect images. the ge nm/ct 850 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the ge nm/ct 860 system is intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. it includes a general purpose nuclear medicine system using a variety of scanning modes supported by various acquisition types, and a computed tomography system which is intended for enabling attenuation correction and anatomical localization of spect images and for standalone head, whole body and vascular x-ray computed tomography applications. the ge nm/ct 860 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy.

Singapore - engelska - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - radiology / imaging - the nm/ct 870 dr system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. the system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. the lung cancer screening option for qualified ge ct systems is indicated for using low-dose ct for lung cancer screening. the screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.