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The intended uses of this system and its accessories are as follows: Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

The devices referenced in this submission represent a highly portable, softwarecontrolled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes or deviations from indications for use different from those demonstrated in previously cleared devices, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 4 (±12%) MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8.0 (±20%) MHz; A probe EC, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8,0 (±20%) MHz. Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.

The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those connonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Seeker/Spark Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a stand-alone enclosure with separate control panel, for connection to a host PC via a USB port: A probe, 128 element convex array (for Seeker only), at an ultrasonic frequency of approximately 4 MHz, model CLA4, part number 9650-0003. A probe, 128 element convex endocavity array at an ultrasonic frequency of approximately 6.5 MHz, model ENDO-6.5, part number 9650-0001. A probe, 128 element linear array at an ultrasonic frequency of approximately 10 MHz, model L10, part number 9655-0003. A probe, 128 element linear array at an ultrasonic frequency of approximately 12 MHz, model L12, part number 9655-0002. A probe, 128 element linear array at an ultrasonic frequency of approximately 16 MHz, model HFLA, part number 9655-0004. Software able to reside in a Windows-based PC inclusive of a non-metrological 3-D image rendering capability.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Imaging: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel and Needle Guidance.

The devices referenced in this submission represent a highly portable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or indications for use different from those demonstrated for B-Mode, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 4 MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan of approximately 8 frames per second at an ultrasonic frequency of approximately 10 MHz; Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.