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510(k) Data Aggregation
K Number
K080351Device Name
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
Manufacturer
Date Cleared
2008-04-22
(71 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DEXELA LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DexTop Mammography Workstation is a mammography review workstation software package, which provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar, medical image data.
The DexTop Workstation is designed to assist the radiologist in conducting screening and primary diagnosis through flexible, fast and efficient image hanging and processing of multimodality softcopy images with special emphasis and optimization for mammography.
When interpreted by a skilled physician, this software provides information that may be useful in screening and diagnosis. However, the final judgment must rely on the knowledge and skill of the physician.
Device Description
The DexTop Mammography Workstation is a software product, which runs on a high end personal computer, for the purpose of non-invasive multi-modality review. It provides very high performance viewing, processing and analysis of multimodality two and three dimensional, as well as planar medical image data.
The DexTop Mammography Workstation receives digital image data from various sources including a variety of diagnostic imaging systems, Hospital PACS, Electronic media and local file systems.
The architecture of the DexTop Workstation means that it can be deployed as a central base station with satellite workstations all using the same user configuration store and image data.
The Dexela DexTop Mammography Workstation supports the following image network communications:
- Standard 10/100/1000 Base-T Ethernet protocols .
- . DICOM 3.0 Storage SCP and Query/Retrieve SCU.
- . TCP/IP network layer
The hardware configuration used with the software typically will include a PC, a single standard color monitor, a multi-function keypad (for increased productivity), and two high resolution monitors for mammographic Image review.
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