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510(k) Data Aggregation
K Number
K012009Device Name
MX8000 IDT CT SYSTEM
Manufacturer
MARCONI MEDICAL SYSTEMS, INC.
Date Cleared
2001-09-13
(78 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
MARCONI MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
Device Description
The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
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K Number
K002005Device Name
BOLUSPRO ULTRA
Manufacturer
MARCONI MEDICAL SYSTEMS, INC.
Date Cleared
2000-09-22
(81 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
MARCONI MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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