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QOCA® image Smart RT Contouring System is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by OOCA® image Smart RT Contouring System. The output of QOCA® image Smart RT Contouring System in the format of RTSTRUCT objects are intended to be used by radiation oncology department. QOCA® image Smart RT Contouring System does not provide a user interface for data visualization. System settings, user settings, progress status, and other functionalities are managed via a web-based interface. The software is not intended to automatically detect or contour lesions. Only DICOM images of adult patients are considered to be valid input.

QOCA® image Smart RT Contouring System is a post-processing software used to automatically contour DICOM CT imaging data using deep-learning-based algorithms. OOCA® image Smart RT Contouring System contouring workflow supports CT inout data and produces RTSTRUCT outputs. Contours that are generated by QOCA® image Smart RT Contouring System may be used as input for clinical workflows including external beam radiation therapy treatment planning. The output of QOCA® image Smart RT Contouring System, in the form of RTSTRUCT objects, are intended to be used by radiation oncology department. The output of QOCA® image Smart RT Contouring System must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by QOCA® image Smart RT Contouring System. QOCA® image Smart RT Contouring System includes the following functionality: - Automated contouring of organs at risk (OAR) workflow - Input - DICOM CT - Output - DICOM CT (Original), DICOM RTSTRUCT - Web-based interface of system settings, user settings, and checking progress status QOCA® image Smart RT Contouring System is intended to be used on adults undergoing treatment that requires the identification of anatomical structures in the body considered to be OAR. QOCA® image Smart RT Contouring System is intended to be used in the head, neck, and pelvis regions.

QOCA® image Smart CXR Image Processing System is a software as medical device (SaMD) used, through artificial intelligence/deep learning technology, to analyze chest X-ray images of adult patient, and then identify cases with suspected pneumothorax. This product shall be used in conjunction with Picture Archiving and Communication System (PACS) at the hospital. This product will automatically analyze the DICOM files automatically pushed from PACS, and then make a notation next to the cases with suspected pneumothorax. This product is only used to remind radiologists to prioritize reviewing cases with suspected pneumothorax. Its results cannot be used as a substitute for a diagnosis by a radiologist, nor can it be used on a stand-alone basis for clinical decision-making.

This product, QOCA® image Smart CXR Image Processing System, is a web-based medical device using a locked artificial intelligence algorithm. It provides features such as cases sorting and image viewing, and supports multiple users at a time. After connecting to Picture Archiving and Communication System (PACS) at the hospital, this product is capable of automatically analyzing either posteroanterior (PA) view or anteroposterior (AP) erect view chest X-ray images automatically pushed from PACS. Once a case with suspected pneumothorax is identified, a notation will be made next to the case in question, so the radiologist can prioritize to review cases with suspected pneumothorax in the Viewer Page. This product will not directly indicate, however, the specific portions or anomalies on the image.

The QOCA Portable ECG Monitoring Device is intended to capture continuous electrocardiogram (ECG) information for long-term (up to 14 days). It is indicated for use on adult patients 21 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety, ECG and heart rate data are stored in the device for later viewing by healthcare professionals.

The QOCA Portable ECG Monitoring Device consists of 3 parts: a rechargeable and reusable ECG sensor with Bluetooth technology, a single-use electrode and hydrogel patch, and an optional mobile platform app (QOCA ecg App). The QOCA Portable ECG Monitoring Device provides a continuous, single-channel recording for up to 14 days. The QOCA Portable ECG Monitoring Device records ECG without patient interaction, and patients have the option of pressing the power button on the ECG sensor to trigger an event record. Patients can also choose to use the QOCA Portable ECG Monitoring Device along with a mobile platform app so that the event trigger can be triggered with the App and the data can be transmitted via BLE from the ECG sensor to the mobile platform for display. The subject device provides operational alarms such as lead off detection and battery monitoring. The operational alarms display on both the sensor and QOCA ecg App to inform the patient of the operation status of the sensor. The subject device does not provide any alarms based on physiological data setting. After the recording period (up to 14 days) ends, the patient returns to his/her healthcare provider, and the data stored in the sensor can be transferred to the computer by connecting with a USB cable and viewed with QOCA ecg Reader, a non-device MDDS for displaying data. The device is intended to be used on general care patients who are 21 years of age or older. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis. This device is not intended to be used for real-time and/or continuous patient monitoring.

The Quanta Pulse Oximeter , Model no. Pulse Link 1000 (or QH100) is a handheld pulse oximeter with alarm. It is intended to be used by trained healthcare professionals in hospital, hospital type facilities, as well as in the home care environment . The Pulse Link 1000 Pulse Oximeter is indicated for non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate of patients on fingers (forefinger or middle finger). The Pulse Link 1000 Pulse Oximeter is re-useable. It is indicated for adult patients under no-motion conditions.

The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) is a digital handheid pulse oximeter that displays numerical values for blood oxygen saturation (%SpO2) and pulse rate. It provide audible and visual alarms for both medium and high priority conditions. The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) will typically operate for 24 hours continuously between alkaline battery replacements. The QH100 Oximeter requires no routine calibration or maintenance other than replacement of alkaline batteries and basic cleaning. The Quanta Pulse Oximeter , Model no.: Pulse Link 1000 (or QH100) determines functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Oxygen saturation and pulse rate values are displayed by LCM monitor. On each detected pulse, the LED indicates the health condition of the patient. If the health condition of the patient is bad ( under some specific criteria), the LED will blink red and beeps alarm from the speaker. A sensor disconnect is also indicated by the LED blinking yellow and beeps alarm from the speaker. The remaining energy of the battery is indicated by the marked scale of the battery indicator on the LCM monitor.

The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.

The Quanta Blood Pressure Meter, Model no.: Cardiac Elite 1000 (or QH200) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual). The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD.