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The intended use of the KinetDx, is for the acceptance, transfer, display, storage, and digital processing of diagnostic ultrasound, CT, MRI, and X-ray angiography images, including manipulation and quantification of the images.

KinetDx is a picture archival and communications system (PACS) that includes a dedicated DICOM server used for image and data storage, retrieval, and archiving. The server accepts images and data from DICOM acquisition devices attached to it by way of a network. The system also includes one or more workstations networked with the server, which are used for clinical review of images and data. Workstations also allow editing of patient demographic and clinical data, image manipulation, and preparation of clinician's reports.

The intended use of the CSV12 Software Viewer is acceptance, transfer, display, storage, and digital processing of Cypress diagnostic ultrasound images and image manipulation and quantification. No new intended uses are claimed for the modifications. The intended use of the CSV12 Software Viewer is for the acceptance, transfer, display, storage, and digital processing of Cypress Diagnostic Ultrasound System images, including image manipulation and quantification.

This modification is a software-only version of the Acuson Cypress Diagnostic Ultrasound System Image Viewer and is described as the CSV12 Software Viewer. The modifications implemented in the CSV12 Viewer Software are to provide off-line image management of ultrasound studies and images on a PC and may be operated independently as a software-only product. The CSV12 Software Viewer, when running on a personal computer (PC) duplicates the patient database, study storage, viewing, and quantification capability of the Cypress ultrasound system. This provides clinicians with a simple means of viewing studies off-line. Because it can read the full-resolution R-Theta file formats of the Cypress diagnostic ultrasound images, the CSV12 Software Viewer displays images in real-time without any compression, duplicating the original quality of the images on the Cypress diagnostic ultrasound system.

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications.

The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

For use directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The device is specifically indicated for use in visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The company anticipates that the device will be used for a variety of intravascular and intracardiac imaging applications, consistent with its intended use, including vascular stent placement, monitoring left ventricular function post-surgery; identifying congenital abnormalities before therapeutic procedures; visualizing the relative orientation of diagnostic and therapeutic catheters; and visualizing procedures such as transseptal insertions of other catheters, valvuloplasties, balloon septostomies, septal defect closures, and pacemaker or defibrillator lead insertion or extraction. The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.

The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The AcuNav incorporates a single-use, disposable ultrasonic phased-array imaging transducer, which must be used in conjunction with an Acuson ultrasound imaging platform to generate the acoustic waves and process the information for display to the physician. The catheter is 10 French in diameter and 90 cm in insertable length. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The distal end of the catheter contains the transducer, which is oriented to provide a two-dimensional (90 degree vector) image in a plane parallel to the axis of the catheter. The transducer offers all imaging modes at frequencies between 4.0 and 10.0 MHz.

Fetal Assessment CAP@ 1.1 is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional image processing. Fetal Assessment CAP can import digital 2D or 3D image file formats for 3D display. The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses.

The Fetal Assessment CAP® 1.1 is a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Fetal Assessment CAP® 1.1 is proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images. The data can be acquired by a TomTec acquisition station or B-mode (2D) acquisition capable Ultrasound systems. With the Fetal Assessment CAP a 3 dimensional display can be reconstructed.

The Aspen Ultrasound System with the FreeStyle option provides B-mode images of anatomy in a field of view that extends well beyond a conventional B-mode region of interest. The FreeStyle option can also provide qualitative Color flow information in this extended field of view. The indications for use for each transducer operating with the FreeStyle feature are unchanged and include fetal, small organ, peripheral vessel, abdominal, gynecologic, transrectal, intraoperative, and musculoskeletal uses.

The Aspen Ultrasound System with the FreeStyle feature is a modification of the Aspen Ultrasound System previously cleared as Model 2001, K934915/S1. The FreeStyle feature allows visualization of anatomy over a wider field of view that surrounds a particular region of interest. The feature operates in B-mode and Color Doppler modes for transducers that have been previously cleared by FDA for all indications for use except cardiac, opthalmic, and transcranial uses. The FreeStyle feature operates by collecting a series of B-mode or Color Doppler image frames in real time, storing them, and then forming a larger composite image for display. The composite image can be displayed within seconds of the real time image frame captures or can be stored and displayed at a later time, perhaps at a Picture Archiving and Communications (PACS) review station. The frames can be captured over a 70cm linear distance or less. The process is executed by a Pentium II or III based PC running Windows NT that is cabled to the ultrasound system and which resides on a shelf in the ultrasound system console. The hardware and software of the ultrasound system itself has not been modified except to add keyboard strokes the enables the Freestyle option and transfers control between the PC and ultrasound system. The PC has been programmed to store the B mode and Color Doppler image frames captured by the ultrasound system in DICOM format, to perform 2 dimensional motion analysis to determine frame to frame translation and rotation vectors, and to form the composite extended image using a graphics library function, and to transfer the extended image back to the ultrasound system for display or storage. There is also a caliper measurement capability in the PC software that can be used on the B mode extended images to perform distance and length measurements. The Color Doppler extended images are used to detect the presence or absence of blood flow and are not for quantification.

The Sequoia™ Ultrasound System in conjunction with the administration of ultrasound contrast agents applies ultrasound energy to an organ, vessel/structure to improve opacification, increase delineation, enhance color Doppler and/or spectral Doppler response, increase visualization of blood flow, document uptake of contrast agent and/or demonstrate perfusion of tissue. The images obtained are useful to physicians in detecting normal and abnormal conditions in regions of the body. The Sequoia™ Ultrasound System is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The TE-V5M transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 8L5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 6L3 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 15L8 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 8V5 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 7V3c transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 5 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction in a The 5 v 2c transducer is intended for flamonio incepts as at they have been approved". The 3 V2c transducer is intended for Harmonic Imaging and Contrest Imaging in conjunction ing the support of the same of of alles indications that they have been approved". The 3V2c transducer is intended for flamont maging and the mave been approved". The 8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 5C2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The 4V2 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The EV-8C4 transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved". The Aux CW transducer is intended for Harmonic Imaging and Contrast Imaging in conjunction with legally marketed contrast agents for the indications that they have been approved".

The Sequoia™ Ultrasound System with the Harmonic Imaging with Contrast utilizes the previously cleared Sequoia™ Ultrasound system (Acuson Model 3001- K935595/S1) and its transcutaneous as well as invasive transducers to create 2-D, M-mode, color Doppler and Spectral Doppler displays of acoustic data in conjunction with administration of ultrasound contrast agent. There are two primary methods by which images are created. First, the images are created in primary imaging mode, with exactly the same transmit and receive settings and controls as are utilized for routine ultrasound imaging without contrast agent administration. Second, images are created in harmonic imaging mode, with the images created using the same transmit settings and controls as are utilized for routine ultrasound imaging without contrast agent administration but in addition the receive frequency is a multiple of the transmit frequency. In both primary and harmonic imaging, exams can be performed using the standard frame rates applicable during routine ultrasound exams. the number of cycles utilized in routine exams.