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510(k) Data Aggregation
K Number
K051081Device Name
ESSENPACS
Manufacturer
Date Cleared
2005-05-12
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CYMED ENGINEERING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.
Device Description
ESSENPACS is a DICOM-compliant and server/client architectural software application. It is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. ESSENPACS is implemented on base of the Digital Imaging and Communication in Medicine (DICOM) standard. Therefore, the system provides communications of images and relevant information such as patient demographics and examination data between DICOM-compliant imaging devices and itself.
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