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The AblatePal Radiofrequency Ablation System is designed to provide monopolar radiofrequency (RF) energy to be used for coagulation and ablation of soft tissue. The device is a prescription device.

The AblatePal Radiofrequency Ablation System (subject device) (HFM01-MD2202) is a monopolar radiofrequency (RF) generator with dedicated components and accessories. The generator can be operated in only impedance mode that use various combinations of time, tissue temperature, tissue impedance, and manual control. An interactive touchscreen display allows user input to the generator and displays informational signals and alert messages. Active electrodes are placed in the tissue to deliver RF energy to the tissue to be ablated. Only one electrode can be attached to the generator and can be used individually. During the ablation of tissue, RF current flows from the generator to an active electrode which delivers the current to the patient. The RF current flows from the active electrode through the patient's body tissue to the Neutral Electrode, which recovers the current and returns it to the qenerator. The resistance to the current, provided by the patient's tissue, produces the heat that is necessary for ablation of tissue. The dedicated system components include: - o RF Generator, radiofrequency generator - . Ablation Foot Switch (HFM01-AF0002): Single Foot Switch. Pressing the foot switch that RF Generator starts or stops ablating. - . Power Control Foot Switch (HFM01-AF0001): Double Foot Switch. Pressing the foot switch to adjust power in whole units of Watts that the RF Generator will deliver during the ablation. The blue foot switch can increase the power, and the yellow foot switch can decrease the power. - . Power Cord (WS-001H+WS-002): A line cord that provides AC power to the RFA system. - Electrode Kit (HFM01-AC0001~ HFM01-AC0006), including radiofrequency electrode, inflowo outflow tubing sets and Neutral Electrodes (HFM01-AE0001). The generator is packaged individually and is always supplied with the accessory items: footswitch and cables. The electrode kit HFM01-AC0001~ HFM01-AC0006 is separately packaged. The following AblatePal Radiofrequency Ablation System compatible accessories are single use: - . Electrode Kit (HFM01-AC0001~ HFM01-AC0006), including a radiofrequency electrode, inflow-outflow tubing sets and Neutral Electrodes.

The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, and M modes. The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

The Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode and Color Doppler or a combination of these modes. The Apache Processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the user interface for mode/setting control and image display, acquisition and storage functions. The Apache App is compatible with Android based mobile devices. Verified devices include Samsung Galaxy S10, Google Pixel 4, HTC U11, and LG G85 ThinQ. The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.