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The Test is a qualitative immunoassay intended for non professional / Over The Counter Use for qualitative detection of the human chorionic gonadotropin (hCG) in urine. The test is for use as an aid in the diagnosis of early pregnancy.

A single step, visually read, qualitative immuno-chromatographic single use stick test.

Diagnostic ultrasound imaging of human soft tissues. The DEI System acoustical holography imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Small organ imaging is intended for the breast. Breast biopsy.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific acoustic output levels (track 1). Its function is to acquire ultrasound data in accustical holography mode and display it on an LCD monitor. The DEI System is similar to the predicate device (OS-2000, k001510) in that both use an oblect transducer that is coupled to the patient by use of a water-path (immersion in water bath or use of water bladders) to transmit pulsed ultrasound through the targeted tissues. These transmitted pulses are then acoustically focused ultrasound beam is then combined with a second plane wave (reference wave) of the same frequency as the transmit wave. The interaction of the transmit wave and the reference wave creates an interference pattern on a target detector device within the enclosed system, forming an acoustic hologram of the object. The detector is illuminated with a coherent light source (laser) resulting in a visual image. The visual image is recorded with a CCD video camera and the images are displayed on a video monitor. Images may be stored to hard disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both allow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of focus (depth plane).

The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific output levels (track 1). Its function is to acquire ultrasound data in acoustical holography mode and display it on an LCD monitor.