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510(k) Data Aggregation
K Number
K072205Device Name
VISAGE PACS/CS, RELEASE VERSION 5.0
Manufacturer
MERCURY COMPUTER SYSTEMS, INC
Date Cleared
2007-08-29
(21 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MERCURY COMPUTER SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: 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 or outside a healthcare enterprise through web clients.
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.
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
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 1
- -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. Instead of image data, a stream of compressed screen content information is transmitted during interaction.
Modification: Implementation of the cardiac analysis option. With the new version of the software the user can import cardiac CT time series in order to utilize them for the LV analysis (analysis of the left ventricle). The LV analysis tool card helps with the analysis of the left ventricle in cardiac CT time series. This toolcard quides the user through an LV analysis step by step. The LV tools support the physician in finding the left ventricle in the image data. The LV tool card supports the user to find and display the long and short axes of the left ventricle and to segment the left ventricle. It supports the user to calculate the total volume of the left ventricle over one heart cycle, the stroke volume and the ejection fraction of the various LV regions and the accumulated wall motion.
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K Number
K062490Device Name
VISAGE PACS/CS, RELEASE VERSION 4.1
Manufacturer
MERCURY COMPUTER SYSTEMS, INC
Date Cleared
2006-10-27
(63 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MERCURY COMPUTER SYSTEMS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Visage PACS/CS: is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: 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 or outside a healthcare enterprise through web clients.
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
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
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. 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. Instead of image data, a stream of compressed screen content information is transmitted during interaction.
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