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510(k) Data Aggregation
K Number
K140797Device Name
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
Manufacturer
Date Cleared
2014-12-12
(256 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISBION LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IPACS Medical Image Management Software is used for viewing medical images.
IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.
IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on aid in pre-operative planning and annotations and measurements to aid in diagnosis.
Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
Device Description
The Visbion IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software is a vendor-neutral PACS (Picture Archiving and Communication System) solution delivering enterprise-wide diagnostic images and patient reports, available for review at any time, from any location using a standard web browser.
IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).
Using a standard web browser registered users have the ability to log in thus provide secure access to images from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities. 24 hours a day.
The device is constructed from the four software elements. These elements are combined according to the configuration required by the user. These terms are used by the user, IPACs being a general term to consolidate the following four elements:
Image Archive
lmage Viewer
Image Web
Image Importer
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