HYGITECH HY-60033 HYGITECH

FerriSmart is a standalone software as a medical device indicated for the evaluation of liver R2 and liver iron concentration (LIC) from MRI images for the full spectrum of R2 and LIC known clinically. It automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.The software application is intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.FerriSmart is indicated to: • Support clinical diagnoses in individuals with confirmed or suspected liver iron overload; • Assessment of liver iron loading to support the subsequent clinical decision-making for patients under management of diseases such as thalassaemia disorders or hereditary haemochromatosis. • Results, when interpreted by a trained physician can be used to support clinical diagnoses about the status of liver iron concentration, the subsequent clinical decision-making processes for the management of iron overload diseases.

The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.

The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g. the reverse osmosis water treatment system).The status of a connected device is signaled:– Visually by three indicator lights (green, yellow, and red)– Acoustically by a sound generatorAn acoustic status signal can be muted temporarily at the touch of a button.The signaling device can currently be operated with the following reverse osmosis systems from Fresenius:– AquaA– AquaBplus

The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center in the monitored areas. It can be used to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices that are connected to the central control unit.This device can be used with the AquaA and AquaBplus water purification systems.

The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories [Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit]. Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037), Robotic Control Unit (RCU) (UDI # 07290018151044) and Unit Cables (UDI # 07290018151051)