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510(k) Data Aggregation
K Number
K033400Device Name
SENO ADVANTAGE
Manufacturer
GE MEDICAL SYSTEMS W-400
Date Cleared
2003-12-04
(41 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
GE MEDICAL SYSTEMS W-400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis.
Device Description
The Seno Advantage Workstation is a multi-modality review workstation. It includes a color flat panel for the multi-modality image review and two specific B&W high resolution monitors for the mammographic images review. Moreover, a dedicated keypad is provided to increase productivity. The Seno Advantage is positioned to be the system of choice for all users of Modality: CT, MR, XR, RF, XA, CR, DX, MG, NM, PET, US, SC. The Hardware configuration of Seno Advantage is the following: HP XW8000 Workstation, Monitors specifications (NEC Flat Panel 18.1" LCD, 2 Grayscale 5 Mpixels CRT), Seno Advantage supports the following image networking: Standard 10/100/1000 Base-T Ethernet Protocols supported: DICOM 3.0 Storage SCU/SCP and Query/Retrieve SCU/SCP, InSite, TCP/IP network layer, SdCNet supported to query/retrieve from AW 3.1 and AW 4.0.
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