Search Results

The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.

The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

This modification has no effect on intended use of the HP ultrasound systems.

The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above.

This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.

This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to the HP SONOS 100CF Ultrasound Imaging System.