Search Results
Found 1 results
510(k) Data Aggregation
K Number
K151957Device Name
BOX DICOM Viewer
Manufacturer
Date Cleared
2015-09-01
(47 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BOX INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BOX DICOM Viewer™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal formation available across a network via web and customized user interfaces. The BOX DICOM Viewer™ is used by hospitals, imaging centers, radiologist reading practices.
Contraindications: The BOX DICOM Viewer™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.
Device Description
The BOX DICOM Viewer™ is a software system to be used to view DICOM compliant studies, which are stored. The BOX DICOM Viewer™ is intended for professional use only as a viewing tool for medical image studies.
The BOX DICOM VIEWER software allows for acquisition of images from DICOM devices and lets users view those images from their personal computers. A third party DICOM device sends to the Box DICOM Proxy listener, the files are then sent to the Upload Proxy, then to the DICOM processor where the DICOM header data is extracted. Finally, the BOX DICOM VIEWER will communicate with a database component to store all the information required for patients, users, studies and configuration settings.
Ask a Question
Ask a specific question about this device
Page 1 of 1