(49 days)
No
The document describes software updates focused on adding new scanning sequences, increasing parameter ranges, and incorporating standard image post-processing techniques (adaptive filters, sensitivity correction). There is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data for tasks like image analysis or diagnosis support. The image processing techniques mentioned are described as "similar to those used in CT," which are typically deterministic algorithms, not AI/ML.
No
The document explicitly states that the device is "an imaging device" intended to "provide the physician with physiological and clinical information" and "images that display the internal structure," which are characteristics of a diagnostic device, not a therapeutic one. The images are described as being "useful in diagnosis determination" when interpreted by a physician.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images "When interpreted by a trained physician. these images provide information that can be useful in diagnosis determination." This clearly indicates its role in aiding diagnosis.
No
The device description explicitly states that the software is a revision to the operating system of existing MR systems (AIRIS and MRP-7000). These MR systems are hardware devices that produce images. The software enhances the functionality of these hardware devices, but it is not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" that provides "physiological and clinical information, obtained non-invasively." It produces images of internal structures. This is characteristic of an in-vivo imaging system, not an in-vitro diagnostic device.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not analyze specimens.
- Device Description: The description focuses on the software revisions for an MR system, which is an imaging modality that interacts directly with the patient's body (in-vivo).
- Input Imaging Modality: Magnetic Resonance (MR) is an in-vivo imaging technique.
The device is a Magnetic Resonance (MR) system, which is a type of medical imaging equipment used for in-vivo diagnosis.
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
90LNH
Device Description
The AIRIS Operating System Software is revised to Version 3.7 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 3.7 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.
Version 3.7 Operating System revisions include the addition of Dynamic Scan measurement and analysis, MTC (magnetization transfer contrast) and SSP (sloped slab profile) for 3D TOF MRA, additional 2D TOF, 2D, and 3D SARGE sequences (steadystate acquisition with gradient rephasing), increased SE and FSE Flip Angle range to 60° - 120°, addition of Fast IR and High Resolution / High Definition Fast IR image acquisition software, addition of High Resolution / High Definition FSE, three additional adaptive filter image post-processing techniques, and Receiver Coil sensitivity correction image post-processing. 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 71 and T2 all may contribute to image contrast. In addition, by varving 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
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.
image processing
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
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 Version 3.4C Operating System Software, Hitachi MRP-7000 with Version 3.3B Operating System Software
Reference Device(s)
K905834, K920441A, K925009, K926397, K934485, K935664, K935671
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
510(K) SUMMARY
.
SUBMITTER INFORMATION: 1.0
- Hitachi Medical Systems America 1.1 Submitter: 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425-1313 FX: 216 425-1410
- James Jochen Rogers 1.2 Contact:
- January 11, 1996 1.3 Date:
DEVICE NAME: 2.8
- Magnetic Resonance Diagnostic Device 2.1
- System, Nuclear Magnetic Resonance Imaging 2.2 Classification Name:
- 90LNH 2.3 Classification Number:
- Version 3.7 Operating System Software 2.4 Trade/Proprietary Name:
- 2.5 PREDICATE DEVICE(s):
Hitachi AIRIS with Version 3.4C Operating System Software Hitachi MRP-7000 with Version 3.3B Operating System Software
DEVICE DESCRIPTION: 3.0
- 3.1 FUNCTION
The AIRIS Operating System Software is revised to Version 3.7 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 3.7 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.
Version 3.7 Operating System revisions include the addition of Dynamic Scan measurement and analysis, MTC (magnetization transfer contrast) and SSP (sloped slab profile) for 3D TOF MRA, additional 2D TOF, 2D, and 3D SARGE sequences (steadystate acquisition with gradient rephasing), increased SE and FSE Flip Angle range to 60° - 120°, addition of Fast IR and High Resolution / High Definition Fast IR image acquisition software, addition of High Resolution / High Definition FSE, three additional adaptive filter image post-processing techniques, and Receiver Coil sensitivity correction image post-processing.
For previous FDA 510(k) submissions, option software such as Fast Spin Echo, 2D and 3D TOF MRA, and Dual Slice, and option software enhancements [modifications requiring the submission of a 510(k) pre-market notification), have traditionally been documented through separate FDA 510(k) pre-market notification submissions; (Cf. K905834, K920441A, K925009, K926397, K934485, K935664, K935671). For the purposes of simplification, current enhancements to option software which would otherwise be documented through separate 510(k) submissions will also be included as part of this 510(k) submission.
1
SCIENTIFIC CONCEPTS 3.2
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 timevarying magnetic gradient fields have a typical duration of sub-millisecond to several milliseconds.
PHYSICAL AND PERFORMANCE CHARACTERISTICS 3.3
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 71 and T2 all may contribute to image contrast. In addition, by varving 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.
2
- Head, Body, Spine, Extremities Anatomical Region:
- Nucleus excited: Proton .
- 2D T1- / T2-weighted imaging Diagnostic uses: C T1, T2, proton density measurements
- MR Angiography
- image processing
- MR Angiography
- 2D, 3D Spin Echo (SE) Imaging capabilities: .
- 2D Fast Spin Echo (FSE) 2D Inversion Recovery (IR)
- 2D Fast Inversion Recovery (FIR)
- 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, MTC, SSP, half echo, high resolution/high definition)
DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0
Identical to the Predicate Device.