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510(k) Data Aggregation
K Number
K050236Device Name
FISHVIEW
Manufacturer
APPLIED SPECTRAL IMAGING, LTD.
Date Cleared
2005-06-27
(147 days)
Product Code
LNJ
Regulation Number
864.5260Why did this record match?
Product Code :
LNJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.
In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.
The FISHView system does require and relies on the operator to analyze the digitized microscope images.
Device Description
The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.
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K Number
K012103Device Name
BANDVIEW SYSTEM
Manufacturer
APPLIED SPECTRAL IMAGING, LTD.
Date Cleared
2001-09-14
(71 days)
Product Code
LNJ
Regulation Number
864.5260Why did this record match?
Product Code :
LNJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment.
The BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.
Device Description
The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software.
The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.
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