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510(k) Data Aggregation
K Number
K041542Device Name
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
Manufacturer
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
Date Cleared
2004-06-17
(9 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
Device Description
The CT-C300DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are a whole body X-ray computed tomography scanner which features a continuously rotating tube-detector system and multi-slice capability of up to 2 slices simultaneously . The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation.
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K Number
K033315Device Name
SUPEROPEN 0.23T, MODEL NAM-P023A
Manufacturer
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
Date Cleared
2003-10-29
(14 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Superopen 0.23T is an imaging device, and 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, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by 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.
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, MR Angiography, Imaging processing
Imaging capabilities: 2D, 3D Spin Echo( SE ), Short time inversion recovery (STIR), Fluid attenuated inversion recovery (FLAIR), 2D,3D Field Echo (FE), 2D, 3D Field Echo with Spoiler (FESP), 2D FESP Multi-Slice (FESP-MS), 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID), 2D, 3D Fast Spin Echo (FSE), 2D, 3D MRCP, MR Angiography, 2D, 3D TOF, MTC
Device Description
The Superopen 0.23T is a 0.23T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
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K Number
K030918Device Name
SUPEROPEN 0.35T, MODEL NSM-P035
Manufacturer
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
Date Cleared
2003-04-01
(8 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Superopen 0.35T is intended to produce images that 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 determining a diagnosis.
The Superopen 0.35T is an imaging device, and 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, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by 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.
Diffusion weighted imaging
MR Angiography
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:
Imaging capabilities:
Imaging processing 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D.3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS) 2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP MR Angiography 2D, 3D TOF MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion
Device Description
The Superopen 0.35T is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.
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K Number
K020913Device Name
CT-C3000 SPIRAL CT SCANNER SYSTEM
Manufacturer
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
Date Cleared
2002-04-03
(13 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
Device Description
Not Found
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