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510(k) Data Aggregation
K Number
K151074Device Name
Magnetic Reasonance Imaging System
Manufacturer
Date Cleared
2015-12-22
(244 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU MAGSPIN INSTRUMENT CO.,LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Magnetic Resonance Imaging System produces transversal, sagittal and oblique cross-section images of the limbs and joints. It's intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, and imaging portion of the leg, including the foot, ankle, calf and knee, but excluding the thigh.
Magspin's magnetic resonance imaging system is a fixed system, it produces images correspond to the spatial distribution of protons (hydrogen nuclei) that embodies magnetic resonance properties of human body and is weighted by the MR parameters such as spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density and "chemical shif". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Device Description
Magnetic Resonance Imaging System produces images of the internal structures of the patient's limbs and joints.
The MRI system consists of the following components:
- Permanent Magnetic
- Magnetic Gradient system
- Dedicated RF coils
- Spectrometer
- Radiofrequency Transmitter
- Receiver coil
- Computer equipped with imaging software
- Patient chair
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