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Found 9 results
510(k) Data Aggregation
K Number
K093044Device Name
OASIS MRI SYSTEM
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2010-03-16
(167 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
This package is indicated for use as follows:
Anatomical Region: Head, whole body Nuclei Excited: "H
Device Description
MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.
The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".
The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.
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K Number
K071506Device Name
ECHELON SPECTROSCOPY PACKAGE
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2007-06-28
(27 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.
This package is indicated for use as follows:
Anatomical Region: Head, whole body 1H Nuclei Excited:
Device Description
MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.
The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".
The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.
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K Number
K011604Device Name
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
Manufacturer
GE MEDICAL SYSTEMS, INC.
Date Cleared
2001-08-22
(90 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative concentrations of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.
Device Description
PROSE is a version of the PRESS (Point RESolved Spectroscopy), "double" spin echo pulse sequence that uses a 90° and two slice selective refocusing RF pulses to generate a spin echo from a localized volume. PROSE utilizes the standard Graphic Prescription tools and one or more sets of localizer images to determine the size and location of the spectroscopic volume.
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K Number
K010129Device Name
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
Manufacturer
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
Date Cleared
2001-04-05
(79 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003575Device Name
MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM
Manufacturer
GE MEDICAL SYSTEMS
Date Cleared
2001-01-17
(58 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991568Device Name
MR SPECTROSCOPY PACKAGE
Manufacturer
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
Date Cleared
1999-07-19
(75 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.
This package is indicated for use as follows:
Anatomical region: Head, whole body
Nuclei Excited: 1H
Device Description
Picker's MR Spectroscopy Package described in this submission is a proton ('H) spectroscopy software option. The package includes both capabilities for single voxel proton (SVP) spectroscopy and chemical shift imaging (CSI). These techniques provide a non-invasive method for analyzing metabolite concentrations in the brain and throughout the body. The MR Spectroscopy Package does not include any additional risks to the patient other than those for standard MR imaging.
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K Number
K984167Device Name
SAGE 7
Manufacturer
GE MEDICAL SYSTEMS
Date Cleared
1999-01-12
(53 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SAGE 7 is a package of software tools for MR spectroscopic data processing and display. SAGE 7 is indicated for use for a wide variety of MR spectroscopic data management tasks, including file handling, display, processing/modeling, analysis, storage and hard copy output. The resultant spectroscopic presentations, when interpreted by a trained physician, can provide physiological / chemical information that can be useful in determining a diagnosis.
Device Description
The GE SAGE 7 Spectroscopy Analysis Software is designed to operate on GE Signa Horizon Systems and GE Advantage Windows workstations. It provides a toolkit of software applications to handle a wide variety of tasks associated with spectroscopy data management. The SAGE (Spectroscopy Analysis GE) package provides the capability for the trained clinical spectroscopist to reconstruct, analyze, and display spectra and spectroscopic images to provide information to support a diagnosis. SAGE 7 provides a tool for the spectroscopist to process raw spectroscopy data into spectra or spectroscopic images, view them, and optionally perform numerical analyses to obtain spectroscopic parameters (ex. peak positions, widths, heights, areas, etc.).
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K Number
K962627Device Name
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
Manufacturer
SIEMENS MEDICAL SOLUTIONS USA, INC.
Date Cleared
1997-04-03
(272 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.
Device Description
The new Clinical Phosphorus Spectroscopy Option for the MAGNETOM VISION consists of hardware/software extensions, a new rf surface coil, and a new quality assurance phantom.
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K Number
K970005Device Name
GYREX 2T-PRESTIGE
Manufacturer
ELSCINT, INC.
Date Cleared
1997-03-28
(85 days)
Product Code
LNI
Regulation Number
892.1000Why did this record match?
Product Code :
LNI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The current modification to the Gyrex 2T-Prestige consists of the addition of software to enable the production of 'H spectra are produced using the existing MRI hardware.
The spectroscopy software includes automated shimming, water suppression, transmitter calibration, central frequency calibration, phase correction and display, and higher level spectral processing functions.
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