(87 days)
Not Found
K9903318, K945155
No
The document describes software updates focused on improving imaging sequences, calibration, and image processing techniques, but does not mention AI or ML.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" useful in "diagnosis determination," and it "produces transverse, coronal, sagittal, oblique, and curved cross-sectional images." It does not mention any therapeutic function or the administration of treatment.
Yes
The "Intended Use / Indications for Use" section states that the magnetic resonance (MR) system provides information that "can be useful in diagnosis determination," and it provides "physiological and clinical information."
No
The device described is operating system software for an MR system, which is a hardware imaging device. The software controls and enhances the functionality of the physical MR scanner.
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 "non-invasive" means. It produces images of the internal structure of the body.
- Mechanism of Action: The device works by utilizing magnetic resonance properties of protons to create images. This is an imaging technique, not a diagnostic test performed on biological samples in vitro (outside the body).
- IVD Definition: IVD 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 process such specimens.
The device is a medical imaging system used for diagnosis based on the interpretation of images by a trained physician. This falls under the category of medical devices, but specifically imaging devices, not IVDs.
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 crosssectional 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 4 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 4 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.
Version 4 Operating System revisions include automatic per patient RF Gain calibration for improved fat suppression, daily- or per-patient x- y- and z-axis gradient offsets for regional shimming, MR cholangiography sequences (MRCP) for improved imaging of the biliary tract, Fluoroscopic MR imaging sequences for 'nearreal-time' imaging, FLAIR (fast low-angle inversion recovery) sequence for suppression of CSF signal, segmented K-space SARGE sequence for time-improved cardiac imaging, addition of rephasing to several FSE sequences, addition of RS (RF Spoiled) SARGE sequence, improved method for body return artifact rejection, submillimeter slice thickness for 3DTOFMRA sequences, reduced slice interval for 3D TOF/GE/SARGE/SE acquisitions, high-definition imaging by 512 matrix reconstruction, short TE SE sequences (TE=9, 10ms), addition of rephasing to 3D SARGE sequence, 'whole echo' 3DTOFMRA, non-linear window for MRA, brightness normalization for selected images with the same acquisition parameters within a patient study, and ACR/NEMA/DICOM 3 support.
In addition, the MRP-7000 and AIRIS Operating System Software are modified to change the maximum SAR limit from 0.4 W/kg to 1.0 W/kg as permitted under the International Electrotechnical Commission (IEC) standard Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis.
Mentions image processing
- image processing
- image processing techniques similar to those used in CT.
- Adaptive Image post-processing
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
Not Found
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 3.7 Operating System Software, Hitachi MRP-7000 with Version 3.7 Operating System Software
Reference Device(s)
K9903318, K945155
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
t quedrypessy
รรอบองคุ้าวอิติษั จักร พุทธศิลปิน พิเศษทานนิย์ (x)015
1
1
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:
- April 4, 1997 1.3 Date:
2.0 DEVICE NAME:
- 2.1 Magnetic Resonance Diagnostic Device
- System, Nuclear Magnetic Resonance Imaging 2.2 Classification Name:
- 2.3 90LNH Classification Number:
- Version 4 Operating System Software 2.4 Trade/Proprietary Name:
2.5 PREDICATE DEVICE(s):
Hitachi AIRIS with Version 3.7 Operating System Software Hitachi MRP-7000 with Version 3.7 Operating System Software
DEVICE DESCRIPTION: 3.0
- FUNCTION 3.1
The AIRIS Operating System Software is revised to Version 4 to increase the clinical utility of the AIRIS in the stationary configuration. The MRP-7000 Operating System Software is revised to Version 4 to increase the clinical utility of the MRP-7000 in both stationary and mobile configurations.
Version 4 Operating System revisions include automatic per patient RF Gain calibration for improved fat suppression, daily- or per-patient x- y- and z-axis gradient offsets for regional shimming, MR cholangiography sequences (MRCP) for improved imaging of the biliary tract, Fluoroscopic MR imaging sequences for 'nearreal-time' imaging, FLAIR (fast low-angle inversion recovery) sequence for suppression of CSF signal, segmented K-space SARGE sequence for time-improved cardiac imaging, addition of rephasing to several FSE sequences, addition of RS (RF Spoiled) SARGE sequence, improved method for body return artifact rejection, submillimeter slice thickness for 3DTOFMRA sequences, reduced slice interval for 3D TOF/GE/SARGE/SE acquisitions, high-definition imaging by 512 matrix reconstruction, short TE SE sequences (TE=9, 10ms), addition of rephasing to 3D SARGE sequence, 'whole echo' 3DTOFMRA, non-linear window for MRA, brightness normalization for selected images with the same acquisition parameters within a patient study, and ACR/NEMA/DICOM 3 support.
2
In addition, the MRP-7000 and AIRIS Operating System Software are modified to change the maximum SAR limit from 0.4 W/kg to 1.0 W/kg as permitted under the International Electrotechnical Commission (IEC) standard Part 2: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis.
Because of the recent approval of the IEC-601-2-33 standard on MR safety, Hitachi seeks to take advantage of the acceptance of the higher SAR level permitted under that standard for the general patient population. We believe that the FDA has accepted the provisions of the IEC standard with respect to its SAR requirements, in compliance, we interpret the FDA's position with regard to the IEC standard for SAR as superceding its previous limit for SAR (up to 0.4 W/kg whole body is of no concern), and no further evidence is necessary beyond that given in the IEC standard and its rationale.
The Hitachi MRP-7000 and AIRIS MR Devices were originally cleared for marketing with an SAR limit of 0.4 W/kg (K9903318 [MRP-7000], and K945155 [AIRIS]), in compliance with the FDA's August 2, 1988 "Guidance for the Content and Review of a Magnetic Resonance Diagnostic Device 510(k) Application". In the FDA guidance, Safety Parameter Action Levels limit SAR to ≤ 3.2 W/kg averaged over the head, to ≤ 0.4 W/kg whole body, or to demonstrate that exposure to RF fields is insufficient to produce a core temperature increase in excess of 1℃ and localized heating greater than 38°C in the head. 39°C in the trunk, and 40°C in the extremities.
The IEC standard, in defining the NORMAL OPERATING MODE, allows SAR values up to 1.5 W/kg under conditions of favorable environmental conditions ( a scan room temperature