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510(k) Data Aggregation
K Number
K063037Device Name
CENTARISONE RIS/PACS
Manufacturer
CENTARISONE, LLC
Date Cleared
2006-10-18
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CENTARISONE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CentarisOne™ RIS/PACS is intended for use by a physicians and other medical staff as a full service DICOM and IHE compliant RIS/PACS solution for the storage, distribution and display of medical images from various imaging sources such as CT, MRI, NM, PT, DR, CR, US, XA scanners and secondary capture devices (film digitizers, etc.). This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images by this device.
Device Description
The CentarisOne™ RIS/PACS is a comprehensive DICOM and IHE compliant radiology software based solution for small to mid-sized imaging centers. The RIS maintains control over all patient related information. The product integrates the imaging aspect with the front office details of the imaging center. It provides all users of the system with more information about the activities of a patient. This all leads to a smoother workflow and better patient care. The PACS component manages the image storage and image display to end-users while tightly integrated into the radiology information system (RIS) to provide users with more patient information resulting in a tighter work-flow.
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