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The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages. When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic. Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

The Veo Reconstruction Option is composed of Server hardware and reconstruction software. The Veo reconstruction Server is connected to the CT system's operator console via a dedicated Ethemet connection to receive raw scan data for processing and send back the reconstructed image data when completed. Additionally, some minor changes to the CT system software are made to include functionality for installation and operation of the Veo Reconstruction Option. The option when used with the Discovery CT750 HD system (K081105) is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. The product changes are primarily associated with the new reconstruction software and hardware. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system. The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases. The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD.

The FRAX™ 10-Year Fracture Risk software option is an accessory to currently marketed GE Lunar bone densitometer devices, which are intended to estimate the bone mineral density and body composition (lean and fat tissue mass) of patients when medically indicated by their physicians. This software option is intended to provide an assessment of 10-year fracture risk. The option provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and medical conditions leading to reduced bone density, and ultimately in the assessment of fracture risk.

This software option is intended to provide an assessment of 10-year fracture risk. The option provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the patient's age, sex, country, ethnicity, height, weight, femur neck BMD T-score, and the presence or absence of several risk factors and is computed using the FRAX™ Fracture Risk Assessment Tool endorsed by the World Health Organization (WHO). The tool has been validated for men and post-menopausal women between 40 and 90 years old. The output is provided in a separate screen display and report that can be viewed or printed or exported to an optional physician report generator tool.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular (PV), Musculo-skeletal Conventional, Urology (including prostate), Transesophageal, Transvaginal (TV), and Intraoperative (abdominal, thoracic, & vascular).

The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter weight package.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate): Transesophageal (TE): Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).

The GE LOGIQ P6 is full-featured, general-purpose diagnostic ultrasound system consisting of a mobile console approximately 49 cm wide, 64 cm deep and 135-141 cm high that provide digital acquisition, processing and display capability. The user interface includes a computer keyboard. specialized controls and color video LCD display. The modification combines features of the unmodified system with additional features from other systems currently marketed by GE Healthcare to provide users with improved imaging capability and acoustic control.

The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional, Transrectal and Transvaginal.

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ-i, LOGIQ-e and Vivid-e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

Diagnostic ultrasound imaging or motion analysis of the human body as follows: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.

The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The GE Vivid S5/S6 is a mobile ultrasound console having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular a and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.

The GE LOGIQ Works Image Analysis and Review Workstation is optimized for ultrasound images that are acquired primarily via the GE LOGIQ family of diagnostic ultrasound systems. It is sold with or without the designated computer hardware.

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

The Voluson E8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 57 cm wide, 96 cm deep and 149 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10 inch LCD touch screen and color 15 inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.