(88 days)
Not Found
Not Found
No
The document describes an ECG monitor accessory for an MRI system and mentions image processing techniques similar to CT, but there is no mention of AI, ML, or related concepts.
No.
The device is described as an "imaging device" intended to provide "physiological and clinical information" useful in "diagnosis determination," and the ECG monitor is an accessory for an MRI system. These functions are diagnostic, not therapeutic.
Yes
The text explicitly states, "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This indicates the device aids in the diagnostic process.
No
The device description explicitly mentions hardware components like an ECG Monitor (Model DS-3130/3140) and its integration with MRI systems (AIRIS and STRATIS). It also discusses physical characteristics like stripchart recorders. This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MR system is an "imaging device" that provides "physiological and clinical information" through "images." It is used to visualize the internal structure of the body.
- Device Description: The device description focuses on the MR system itself and an accessory ECG monitor used for gating during the imaging process.
- Nature of Information: The information provided by the device is in the form of images reflecting the spatial distribution of physical properties (proton density, relaxation times, flow). This is distinct from IVD devices which analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
IVD devices are specifically designed to perform tests on biological specimens to diagnose diseases or other conditions. This MR system is an imaging modality that provides visual information about the body's internal structure.
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, 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
Product codes
90LNH
Device Description
The Fukuda Denshi ECG Monitor Model DS-3130/3140 is being added to increase the clinical utility of the AIRIS and STRATIS in the stationary configuration. The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS. The Model DS-3140 ECG Monitor has a stripchart recorder, the Model DS-3130 does not. As with the previous version of the ECG Monitor, the Model DS-3130/3140 supports ECG, peripheral pulse and respiratory gating; respiratory gating is not supported on the AIRIS. The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems.
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 wavelength 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 time-varying magnetic gradient fields have a typical duration of submillisecond to several milliseconds. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, Spine, Extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained 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 AIRIS with ECG Monitor, Hitachi STRATIS with ECG Monitor
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
K96 1174
JUN 21 1996
Attachment 1 510(k) Summary of Safety and
Effectiveness
P
1
SUBMITTER INFORMATION:
- 1.1 Hitachi Medical Systems America Submitter: 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425 1313 FX: 216 425 1410
- 1.2 Contact: James Jochen Rogers
- 1.3 Date: March 21, 1996
2.0 DEVICE NAME
- Classification Panel: 2.1 Radiology 2.2 Classification Number: 892.1000 Magnetic Resonance Diagnostic Device 2.3 Product Number: 90LNH 2.4 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging 2.5 Trade/Proprietary Name: ECG Monitor Model DS-3130/3140 2.6 Predicate Device: Hitachi AIRIS with ECG Monitor
Hitachi STRATIS with ECG Monitor.
3.0 DEVICE DESCRIPTION:
FUNCTION 3.1
The Fukuda Denshi ECG Monitor Model DS-3130/3140 is being added to increase the clinical utility of the AIRIS and STRATIS in the stationary configuration. The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS. The Model DS-3140 ECG Monitor has a stripchart recorder, the Model DS-3130 does not. As with the previous version of the ECG Monitor, the Model DS-3130/3140 supports ECG, peripheral pulse and respiratory gating; respiratory gating is not supported on the AIRIS. The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems.
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 wavelength 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.
- 1.0
2
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 time-varying magnetic gradient fields have a typical duration of submillisecond 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, 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
3
Imaging capabilities: ●
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ
2D, 3D Spin Echo (SE) 2D Fast Spin Echo (FSE)
2D Inversion Recovery (IR)
2D, 3D Gradient Echo (GE)
2D, 3D Gradient Echo with Rephasing (GR)
2D, 3D Steady state acquisition with rewinded GE (SARGE)
2D Dual Slice acquisition (DS)
MR Angiography (2D TOF, 3D TOF, half echo,
high resolution/high definition)
5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS:
Identical to the Predicate Device.