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The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors: - VS 9 Vital Signs Monitor - VS 8 Vital Signs Monitor - VS 8A Vital Signs Monitor . The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

ViewMate Multi Ultrasound System VMM-ICE-01 is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Abdominal, thoracc, and vacular), Pediatric, Small Organ (Thyroid, Breast, Testes), Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Intra-cardiac and Peripheral vessel exams. Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

ViewMate™ Multi Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, TDI, Color M. ViewMate™ Multi Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams. This device is a general purpose diamostic ultrasound system intended for use by qualified and trained healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.

DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B mode, M mode, PW mode, CW mode, Color mode, Power/Dirpower mode, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.

The Accutorr 7/VS-900 Vital Signs Monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP), Temperature (TEMP) and Carbon Dioxide (CO2), on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitor also provides a Modified Early Warning Score (MEWS) for clinical assessment in adult patients.

The Accutorr 7/VS-900 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sy()//Scy(), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: - . The arrhythmia detection. ST Segment analysis of Mortara algorithm. BIS, RM, CCO. SvOz/Scv02, and PAWP monitoring are intended for adult and pediatric patients only: - ST Segment analysis of Mindray algorithm is intended for adult patients only; ● - C.O. monitoring is restricted to adult patients only: ● - ICG monitoring is only for use on adult patients who meet the following ● requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; ST Segment analysis of Mindray ECG algorithm is intended for adult patients only; The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

The subject Passport Series Patient Monitors includes three monitors: - . Passport 12M Patient Monitor - Passport 17M Patient Monitor ● - T1 Patient Monitor All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12M and 17M Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor. The T1 patient monitor is one of the available modules that can be plugged into the Passport 17M or 12M monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17M and 12M. Each of the three monitors that are the subject of this 510(k) are modified versions of previously cleared Mindray devices. The Passport 17M and Passport 12M were previously cleared in K132075, on April 18, 2014 and the T1 was previously cleared in K123074 on July 3, 2013.

The CMS network transfers information between Hypervisor Central Monitoring System and other networked devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and/or WLAN connections. CMS can be used for remote monitor management, storing, printing, reviewing or processing of information from networked devices, and it is operated by medical personnel in hospitals or medical institutions. Telemetry Monitoring System is a sub-system of CMS, intended to obtain ECG and SpO2 physiological information from adult and pediatric patients, and send it to CMS via WMTS frequency within a defined coverage area.

The CMS network is a kind of medical information system, which consists of different networked devices (which have separate 510(k) clearance). CMS is the primary maintainer of communication between other networked devices. It can store, print, review or process information from networked devices. It can also realize remote monitor management function to free doctors from clinical monitoring work and conduct centralized monitoring management.

The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.

The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array, convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 MHz.