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"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perineum and/or abdomen, 2) endocavity, by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

The Halo Medical Technologies, Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a self contained portable, single-mode, and singleapplication ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording. User-customized parameter settings for the MidCRYSTL™ Endoanal, HALO™ Endovaginal and HALO™ Surface Ultrasound Probes may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function. More detailed explanations of these functions and controls are included in the User Manuals, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials have been used in accordance to their intended use and are described below for each individual transducer. The transducers were previously cleared for use on other Systems (K951976 and referenced in K070907). The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System is a B-Mode ultrasound scanner which provides high resolution, high penetration performance. Probes are supported in frequencies from 3.5 MHz to 24.0 MHz. The probes are indicated expressly for endoanal, endovaginal, and/or abdominal/transperineal (surface) application. The Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System provides various measuring functions. It can measure distances and calculate angles. Halo Medical Technologies Catalyst™, MidCRYSTL™, HALO™ Ultrasound System supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device(s), Laborie NuWAV (K081781).