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510(k) Data Aggregation
K Number
K221025Device Name
i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
Date Cleared
2022-07-01
(86 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MRI Division,Beijing Wandong Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
i Field 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained-physician, these images provide information that can be useful in diagnosis determination.
Device Description
i Field 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Field 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the i_Space 1.5T by taking advantage of the imaging properties of the 1.5T magnet.
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K Number
K192650Device Name
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
Date Cleared
2021-01-29
(493 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
MRI Division, Beijing Wandong Medical Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
i Space 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained-physician, these images provide information that can be useful in diagnosis determination.
Device Description
i Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 by taking advantage of the imaging properties of the 1.5T magnet.
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K Number
K090873Device Name
I OPEN 0.5T
Manufacturer
Date Cleared
2009-04-10
(10 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BEIJING WANDONG MEDICAL EQUIPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The i Open 0.5T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.5T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
The i_Open 0.5T is a 0.5 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
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K Number
K090433Device Name
I_OPEN 0.4T
Manufacturer
Date Cleared
2009-03-25
(34 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
BEIJING WANDONG MEDICAL EQUIPMENT CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The i Open 0.4T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.4T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Description
The i Open 0.4T is a 0.4 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
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K Number
K042948Device Name
I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
Manufacturer
Date Cleared
2004-11-03
(8 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
WANDONG MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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