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510(k) Data Aggregation
K Number
K080048Device Name
MSK EXTREME MR SCANNER, MODEL AA5000
Manufacturer
ONI MEDICAL SYSTEMS, INC.
Date Cleared
2008-02-06
(29 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ONI MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
Device Description
The MSK Extreme™ MR Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
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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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