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510(k) Data Aggregation
K Number
K200595Device Name
CellaVision DC-1, CellaVision DC-1 PPA
Manufacturer
CellaVision AB
Date Cleared
2020-10-16
(224 days)
Product Code
JOY
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CellaVision AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CellaVision® DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in clinical laboratories.
CellaVision® DC-1 is intended to be used by operators, trained in the use of the device.
Intended use of the Peripheral Blood Application
The Peripheral Blood Application is intended for differential count of white blood cells (WBC), characterization of red blood cell (RBC) morphology and platelet estimation.
The CellaVision® DC-1 with the Peripheral Blood Application automatically locates blood cells on peripheral blood (PB) smears. The application presents images of the blood cells for review. A skilled operator trained in recognition of blood cells, identifies and verifies the suggested classification of each cell according to type.
Device Description
The CellaVision® DC-1 is an automated cell-locating device intended for in-vitro diagnostic use. CellaVision® DC-1 automatically locates and presents images of blood cells found on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. CellaVision® DC-1 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
The CellaVision® DC-1 consists of a built-in PC with a Solid-State Disc (SSD) containing CellaVision DM Software (CDMS), a high-power magnification microscope with a LED illumination, an XY stage, a proprietary camera with firmware, built-in motor- and illumination LED controller, a casing and an external power supply. It is capable of handling one slide at a time.
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K Number
K102778Device Name
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
Manufacturer
CELLAVISION AB
Date Cleared
2011-09-16
(357 days)
Product Code
JOY
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CELLAVISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DM1200 is an automated system intended for in-vitro diagnostic use.
The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type.
DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Device Description
CellaVision DM1200 with the body fluid application automatically locates and presents images of nucleated cells on cytocentrifuged body fluid preparations. The system suggests a classification for each cell and the operator verifies the classification and has the opportunity to change the suggested classification of any cell.
The system preclassifies to the following WBC classes: Unidentified, Neutrophils, Eosinophils, Lymphocytes, Macrophages (including Monocytes) and Other. Cells preclassified as Basophils, Lymphoma cells, Atypical lymphocytes, Blasts and Tumor cells are automatically forwarded to the cell class Other.
Unidentified is a class for cells and objects which the system has pre-classified with a low confidence level.
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K Number
K092868Device Name
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
Manufacturer
CELLAVISION AB
Date Cleared
2009-11-20
(63 days)
Product Code
JOY, GKZ
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CELLAVISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DM1200 is an automated cell-locating device.
DM1200 automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type.
DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Device Description
DM1200 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM1200 consists of a slide scanning unit (a robot gripper, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision® DM software".
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K Number
K080595Device Name
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
Manufacturer
CELLAVISION AB
Date Cleared
2008-12-05
(277 days)
Product Code
JOY, GKZ
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CELLAVISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DM96 is an automated cell-locating device.
The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Device Description
The CellaVision DM96 with the body fluid application is a laboratory instrument used to perform differential analysis by locating, digitally storing and displaying cells in human body fluid preparations.
The CellaVision DM96 with the body fluid application is a new intended use that follows the same process as the currently cleared DM96 with white blood cell differential, RBC characterization and platelet estimation (K033840).
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K Number
K033840Device Name
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
Manufacturer
CELLAVISION AB
Date Cleared
2004-02-10
(62 days)
Product Code
JOY
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CELLAVISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DM96 is an automated cell-locating device.
DM96 automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type.
DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.
Device Description
DM96 is an automated cell-locating device for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. DM96 consists of a slidescanning unit (a slide feeder, a microscope and a camera) and a computer system containing the acquisition and classification software "CellaVision Blood Differential software".
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K Number
K003301Device Name
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
Manufacturer
CELLAVISION AB
Date Cleared
2001-03-15
(146 days)
Product Code
JOY
Regulation Number
864.5260Why did this record match?
Applicant Name (Manufacturer) :
CELLAVISION AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DiffMaster Octavia™ is an automated cell locating device. DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type. DiffMaster Octavia is intended to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.
Device Description
The DiffMaster-Octavia™ is an automated cell locating device for differential count of white blood cells and characterization of red morphology. It is based on a CellaVision AB developed software system Cytologica. DiffMaster Octavia™consists of a commercially available positioning system for the slides, a commercially available microscope, a commercially available camera and the software system.
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