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iPACS Prism-5.0™ from Real Time Image Inc. is a device that receives medical images, (including mammographic images), and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. iPACS Prism-5.0TM only supports lossless compression for primary mammography image interpretation. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions ind other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

iPACS Prism-5.0 is a modified version of iPACS Prism (K030751). Both devices are picture, archiving and communications system software applications from RealTimelmage. The main significant 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 viewing of these images more convenient for the user. Both systems are a complete PACS solutions designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. IPACS Prism-5.0 is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism-5.0 are needed The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.