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Found 2 results
510(k) Data Aggregation
K Number
K061545Device Name
SCENIUM 1.1
Manufacturer
SIEMENS MOLECULAR IMAGING LTD
Date Cleared
2006-06-30
(25 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MOLECULAR IMAGING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workstations and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET and SPECT studies.
Device Description
Scenium 1.1 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data.
The software is post processing and does not control the scanning features of the system.
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K Number
K042863Device Name
SCENIUM
Manufacturer
SIEMENS MOLECULAR IMAGING LTD
Date Cleared
2004-12-15
(58 days)
Product Code
KPS, 90K
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SIEMENS MOLECULAR IMAGING LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET scans. The software is deployed via medical imaging workstations and is organised as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest facilitating comparison with existing scans derived from FDG-PET studies.
Device Description
Scenium display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. The software is post processing and does not control the scanning features of the system.
Ask a Question
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