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510(k) Data Aggregation
K Number
K162868Device Name
Exam Vue PACS
Manufacturer
Date Cleared
2017-03-17
(155 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JPI Healthcare Solutions, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ExamVue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.
The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.
Device Description
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing. modifying, making measurements on, and displaying the images in the database.
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