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Found 3 results
510(k) Data Aggregation
K Number
K024149Device Name
PRIMELUNG
Manufacturer
ACCUIMAGE DIAGNOSTICS CORP.
Date Cleared
2003-02-21
(67 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ACCUIMAGE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.
Device Description
The Acculmage PrimeLung software module is an additional software option to K990241, AccuView Diagnostics Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plug-ins. The AccuShade plug-in is not currently marketed, the AccuMIP plug-in is currently marketed with the name ProjectorPro. The Acculmage PrimeLung plug-in provides visualization and analysis tools for viewing regions of the lung, and generating reports with patient information, images, results and recommendations.
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K Number
K012106Device Name
ACCUIMAGE SMARTGATE UPGRADE
Manufacturer
ACCUIMAGE DIAGNOSTICS CORP.
Date Cleared
2001-09-25
(81 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
ACCUIMAGE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Heart calcium scoring for gated CT images to minimize effects of heart movements.
Device Description
The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.
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K Number
K990241Device Name
ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
Manufacturer
ACCUIMAGE DIAGNOSTICS CORP.
Date Cleared
1999-09-23
(241 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ACCUIMAGE DIAGNOSTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard supplied by and may be purchased independently by the end user or from AccuImage. The AccuImage, AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.
Device Description
The AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receive image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard communication, and them for ease of cost and maintenance. The use of Microsoft Windows 95/98/NT operating system makes the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins easy to use and capable of being integrated with other computer needs.
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