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Found 5 results
510(k) Data Aggregation
K Number
K033013Device Name
MDIFICATION TO MEDIPRIME
Manufacturer
ALGOTEC SYSTEMS, LTD.
Date Cleared
2003-11-25
(60 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOTEC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
Device Description
The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf PCs running Windows 2000/XP operating systems and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Angiography MIP, Vessel Tracking and Tissue Definition.
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K Number
K023936Device Name
MODIFICATION TO MEDIPRIME
Manufacturer
ALGOTEC SYSTEMS, LTD.
Date Cleared
2002-12-20
(24 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOTEC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
Device Description
The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).
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K Number
K002894Device Name
MEDIPRIME
Manufacturer
ALGOTEC SYSTEMS, LTD.
Date Cleared
2000-12-05
(78 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOTEC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K980648Device Name
PRO VISION
Manufacturer
ALGOTEC SYSTEMS, LTD.
Date Cleared
1998-07-20
(151 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOTEC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProVision is an independent diagnostic viewing and processing workstation. It is based on a Silicon Graphics Workstation running under Unix. ProVision communicates with imaging systems of different modalities (currently CT, MRI, CR, RF, NM) utilizing the DICOM - 3 standard. Connection may also be made to any other DICOM device. ProVision functions include :Archiving, displaying, manipulation, filming, 2and 3-dimensional processing. ProVision employs a graphical multi -Window, icon and mouse driven user interface. It is designed to ensure maximum flexibility on the one hand, and intuitive operation on the other.
Device Description
The ProVision is a multi-modality diagnostic Workstation for processing and archiving radiological images. It is based on off-the shelf Silicon Graphics UNIX based computers that comply with the accepted international standards for computer systems. The systems also comprises software developed and validated by Algotec Systems Ltd.
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K Number
K954678Device Name
PRO VISION
Manufacturer
ALGOTEC SYSTEMS, LTD.
Date Cleared
1996-01-05
(87 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOTEC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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