(108 days)
Not Found
No
The document describes various image processing techniques and software updates for an MR system, but it does not mention or imply the use of AI or ML technologies. The focus is on traditional signal processing and image reconstruction methods.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" for "diagnosis determination", indicating it is a diagnostic tool, not a therapeutic one.
Yes
The intended use explicitly states that the MR system provides information that can be useful in diagnosis determination when interpreted by a trained physician.
No
The device is described as "Operating System Software" for an "MR system," which is an imaging device. The description focuses on software revisions that enhance the functionality of the existing MR hardware (STRATIS / MRH-1500). While the submission is about a software update, the device itself is an MR system, which is a hardware device with integrated software. The software is not a standalone medical device but rather a component of a larger hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" that provides "physiological and clinical information" through "non-invasive" means. It produces images of the internal structure of the body.
- Mechanism: The device utilizes Magnetic Resonance (MR) to generate images based on the properties of protons within the body. This is a physical imaging technique, not a method for analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description focuses on software revisions that enhance the imaging capabilities and image processing techniques.
- Input Modality: The input modality is Magnetic Resonance (MR), which is an imaging modality, not a method for analyzing biological samples.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic purposes. This MR system does not analyze such specimens.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MR system 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 MR 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 the MR 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.
Product codes
LNH
Device Description
The STRATIS / MRH-1500 Operating System Software is revised to Version 6 to increase the clinical utility of the STRATIS / MRH-1500 in the stationary configuration.
Version 6 Operating System revisions include the addition of RF spoiling, SSP for enhanced 3D MRA, RF Fat Suppression, MTC for background suppression, 3D-FSE, 3D-FIR, rephase added to 2D-FSE and 2D-GFF, 2D-FIR Dual Contrast, RF coil uniformity image post-processing, and adaptive image post-processing.
Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of waveleneth specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x. y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.
For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The timevarying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hitachi STRATIS with Version 3 Operating System Software, Hitachi MRH-1500 with Version 3 Operating System Software
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
*961969
SEP - 5 1996
Attachment 1
510(k) Summary of Safety and Effectiveness
1
1.0 SUBMITTER INFORMATION:
- 1.1 Submitter: Hitachi Medical Systems Ainerica 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425-1313 FX: 216 425-1410
- 1.2 James Jochen Rogers Contact:
- 1.3 Date: May 15, 1996
2.0 DEVICE NAME:
- 2.1 Magnetic Resonance Diagnostic Device
- 2.2 Classification Name: System, Nuclear Magnetic Resonance Imaging
- 2.3 Classification Number: 90LNH
- 2.4 Trade/Proprietary Name: Version 6 Operating System Software
2.5 PREDICATE DEVICE(s):
Hitachi STRATIS with Version 3 Operating System Software Hitachi MRH-1500 with Version 3 Operating System Software
3.0 DEVICE DESCRIPTION:
- FUNCTION 3.1
The STRATIS / MRH-1500 Operating System Software is revised to Version 6 to increase the clinical utility of the STRATIS / MRH-1500 in the stationary configuration.
Version 6 Operating System revisions include the addition of RF spoiling, SSP for enhanced 3D MRA, RF Fat Suppression, MTC for background suppression, 3D-FSE, 3D-FIR, rephase added to 2D-FSE and 2D-GFF, 2D-FIR Dual Contrast, RF coil uniformity image post-processing, and adaptive image post-processing.
3.2 SCIENTIFIC CONCEPTS
Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of waveleneth specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.
2
These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x. y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.
For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The timevarying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS
MR is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation, T2 relaxation, proton density, or a combination of all three.
4.0 DEVICE INTENDED USE:
The MR system 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 MR 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 the MR 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.
- Anatomical Region: ● Head, Body, Spine, Extremities
- Nucleus excited: Proton
- Diagnostic uses: 2D T1- / T2-weighted imaging T1, T2, proton density measurements
- MR Angiography image processing
- · Imaging capabilities:
2D, 3D Spin Echo (SE) 2D Short Spin Echo (SES) 2D, 3D Fast Spin Echo (FSE) 2D Inversion Recovery (IR) 2D, 3D Fast Inversion Recovery (FIR) 2D,3D Gradient Field Echo (GFE); also with rephasing 2D, 3D Rapid Scan (RS) MTC, RF Spoiling
3
MR Angiography, (2D INFA, 3D INFA, 2D GFEA, 3D GFEA, Sloped Slab Profile (SSP)) RF Coil Uniformity Adaptive Image post-processing
DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0
Identical to the Predicate Device.