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510(k) Data Aggregation

    K Number
    K211863
    Device Name
    eVolve PACS
    Manufacturer
    Date Cleared
    2021-08-12

    (57 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    eVolve PACS Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    e Volve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF, and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software. e Volve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.
    Device Description
    eVolve PACS, uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access eVolve PACS (and RIS) systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of eVolve PACS support, eVolve PACS Inc., performs virtually all the system maintenance. eVolve PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion. eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities: - To store and retrieve various kinds of DICOM Objects such as: - Images from multiple modalities, - Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations, - Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note, - Structured Reports [SR]. - To process HL7 notification messages from the Order Filler, about Procedure Scheduling, Procedure Updates and Patient Information Updates, - To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler. eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators. eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.
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