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Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities. Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.

Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.

Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices. Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols. Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.

Centricity® Perinatal and Centricity Intensive Care is intended to be used as a data management tool with which a medical institution may define electronic forms to acquire device data and to document, annotate, display, store, print, export and retrieve patient/clinical practice information. This product is a primary tool for documentation as well as an adjunct tool for surveillance. The Centricity Perinatal and Centricity Intensive Care (CPN-CIC) is a clinical information system used to manage clinical data. The CPN-CIC may be used in the following clinical settings such as: - Labor and Delivery (Antepartum, Intrapartum) - Postpartum - Newborn Nursery - Critical Care Units (Neonatal Intensive Care, Adult Intensive Care) The CPN-CIC can be used in the hospitals, physician offices, and outpatient clinics where the system can accept and display data from the following sources such as: - Physiologic devices - External hospital and clinical information systems NOTE: This product does not replace clinical observation and evaluation of the patient at regular intervals by a qualified healthcare provider, who will make diagnoses and decide on treatments and/or interventions. Features of the product are intended to support clinical decision making and should be used in combination with other clinical inputs, such as real time patient observation, physical exam findings and information contained within other systems or recording tools. The product is not intended to be used as a primary monitoring or diagnostic device.

The Centricity® Perinatal and Centricity Intensive Care is a data management tool. The basis for this submission is a modification to a legally marketed device. Both the proposed device intended use and indications for use statements are equivalent to that of the predicate device and have been reworded to improve clarity. Since 1999, Data Management Computer Systems and Technology have evolved. GEHC has modified the device by incorporating "state of the art" technology. The most significant changes being listed are: Overall product enhancements for security and privacy (to support HIPAA), interoperability enhancements, clinician notification enhancements, removal of some features only supplied on the old OS/2 platform version, keeping up with technology changes with respect to Windows Operating system, etc. On their own, none of these changes would have triggered a 510k submission. However, it was deemed important to clarify the Intended Use and Indications for use as well as to notify FDA of the current product state since many changes were made to keep up with the evolution of technology.

RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration. Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device. RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The R4600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy is a PC-based DICOM workstation platform which provides scaleable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data. RA600/CA1000 / Digital Hardcopy may be combined with a PACS network or connected directly to a modality through the use of DICOM networking. The RA600/CA1000 / Digital Hardcopy software application may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs. RA600 / CA1000 / Digital Hardcopy can also provide the hardware and OS platform for a user to operate 3rd party software and/or other GE software applications such as RIS, voice recognition, or advanced imaging analysis, and view any data presented through those applications. RA600 / CA1000 can act as an image repository for the Centricity Web Viewer application.