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Voyager PACS System™ is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices. scanners. imaging gateways, etc.). Images and data can be captured. stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.

Voyager PACS is a web enabled PACS system that provides medical images of any patient to any doctor, anytime, anywhere. Voyager PACS is a server based system that allows image archiving, storage, management and distribution. The system receives images from Modalities via DICOM or from other sources (i.e. Teleradiology). Images are stored on the PACS Server. The studies and images on this server can be viewed, reported and manipulated by the Voyager Diagnostic workstations connected to the PACS server via LAN, WAN or Internet connection. Voyager Integrator provides seamless interface to the Radiology Information System (RIS) via HL7, allowing information between the Voyager PACS and the RIS to be shared and exchanged.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Voyager PACS System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document describes the device, its intended use, and its technological characteristics, aiming to satisfy regulatory requirements rather than providing clinical performance data.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the input text. The document states:

• "The 510(k) Pre-Market Notification for Voyager PACS System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."
• "Voyager PACS System™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor"."

These statements indicate that the submission focused on comparing the new device to an existing one and adhering to manufacturing standards and hazard analysis, which are typically part of a 510(k) submission for demonstrating safety and efficacy indirectly, rather than presenting a performance study with specific acceptance criteria.

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