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510(k) Data Aggregation
K Number
K052358Device Name
ETIAM STAR PACS COMPONENTS
Manufacturer
ETIAM, S.A.
Date Cleared
2005-10-05
(37 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ETIAM, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ETIAM STAR PACS Components™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
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.
Device Description
ETIAM STAR PACS Components™ are software applications that make possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to ETIAM STAR PACS Components™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
ETIAM STAR PACS Components™ is a software product that handles digital medical images.
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
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