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510(k) Data Aggregation
K Number
K131392Device Name
ETIAM PACS COMPONENTS
Manufacturer
Date Cleared
2013-05-29
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ETIAM S.A.S.U.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ETIAM PACS Components™ is intended to be used by healthcare personnel to import, review, edit and send medical images.
ETIAM PACS Components™ is not labeled for diagnostic use.
ETIAM 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 meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Device Description
ETIAM 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 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.
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