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To be used with images from a variety of radiological modalities including CT, MRI, ultrasound, nuclear medicine, CR, DR, etc. to store and retrieve images and patient information.

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.

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This is a predicate device letter for JiveX Picture Archiving and Communications System (PACS) from 2006. This type of letter determines substantial equivalence to previously cleared devices under 510(k) regulations. It does not present acceptance criteria or a study demonstrating the device meets them because such studies are not typically required for 510(k) clearances of PACS systems.

PACS devices like JiveX are generally considered "general purpose" devices for viewing, storing, and retrieving medical images. Their substantial equivalence is typically based on demonstrating that they perform the same functions as legally marketed predicate devices, with similar technological characteristics, and do not raise new questions of safety or effectiveness. Performance claims beyond these basic functions would usually require specific studies.

Therefore, I cannot provide the requested information from the provided text as it is not contained within a 510(k) clearance letter for a PACS system.

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