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Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol. Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images. 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 specification reviewed and accepted by FDA. Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.

Connect Imaging PACS is a modified version of Connect Imaging FilmLess Clinic (K031704). Both devices are picture, archiving and communication system software applications from Connect Imaging Inc. The main difference between the modified device and the predicate device is that the modified device will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make the viewing of these images more convenient for the user. Both systems are a complete PACS solution designed for deployment over local area networks, wide area networks, or through web access. Connect Imaging PACS is modular and will be offered under different brand names for different modular parts of the PACS. The Connect Imaging PACS handles various images and data objects in Picture Archiving and Communications System (PACS) environment. The Connect Imaging PACS received digital images in DICOM format from DICOM compliant modalities, as well as digitized analog images using film digitizers that are 510(k) approved. These images are stored in a central archive and distributed to various locations for viewing with an imaging workstation.

Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol. Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images. Filmless Clinic is intended for use by qualified physicians and radiologists and other personnel.

Filmless Clinic is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol. Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review of images.