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510(k) Data Aggregation
K Number
K082269Device Name
VISAGE PACS, VERSION 6.0/CS 3.1
Manufacturer
VISAGE IMAGING, INC.
Date Cleared
2008-12-12
(123 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VISAGE IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visage PACS/CS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments.
The Visage PACS/CS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement.
Besides general image interpretation and processing tools, Visage PACS/CS provides specific tool sets for several clinical applications, including:
- CT/MR angiography, e.g. for vascular analysis and stent planning
- Cardiac analysis, including calcium scoring and functional assessment of cardiac CT data
- Neuroradiology, including CT and MR brain perfusion analysis
- Oncology, including SUV analysis and lesion marking and analysis
Visage PACS/CS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility.
Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws.
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis.
Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.
Device Description
Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:
- Visage PACS Storage
- Visage PACS Web
- Visage CS
Visage PACS Storage: A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement. Visage PACS Storage offers an archiving option for long-term storage of image data.
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients. The image data transfer is done in DICOM format via the Intranet or the Internet. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client.
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