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510(k) Data Aggregation
K Number
K062757Device Name
XERON PACS
Manufacturer
Date Cleared
2006-11-07
(54 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
XERON HEALTHCARE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Xeron PACS is a medical imaging software application intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
Device Description
Xeron PACS is an image management system that allows authorized personnel to acquire, display, edit, review, store, print, and distribute standard Digital Imaging and Communications in Medicine (DICOM) medical images within a Picture Archiving and Communication System (PACS) environment. The Xeron PACS system consists of five software components:
- · XP WebStation
- · XP RadStation
- · XP Site Administrator
- · XP Data Router
- · XP Server Manager
Xeron PACS supports DICOM network structures which allow for efficient medical image acquisition from any medical modality, including CT, MR, CR, and others. Distribution of images is provided to desktop computer systems, computer systems connected by intranet or internet, hardcopy devices, and Hospital Information Systems (HIS).
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