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510(k) Data Aggregation
K Number
K042008Device Name
ULTRAVISUAL
Manufacturer
EMAGEON UV, INC.
Date Cleared
2004-09-03
(39 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EMAGEON UV, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by modality and user; rotate images in 90-degree increments; flip image horizontally or vertically; customize display of on-screen user and patient demographics; sharpen, edge and blur filters; key image creation for communicating with other physicians, and multiple display support. Images can be displayed in any configuration or format the user specifies and associates with that specific user's profile. All display protocols and user configurable settings follow the user throughout the enterprise.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.
Device Description
Emageon UV, Inc.'s Ultravisual™ software is integrated client-server software package comprised of features that were previously cleared in Vortex TM 510(k): K012097. The main difference is that the software will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user.
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