(78 days)
Not Found
No
The document describes modifications to the operating system software of an MR system to change a SAR limit and mentions standard image processing techniques. 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 it "produces ... images that display the internal structure." This aligns with diagnostic rather than therapeutic use.
Yes
The text states, "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This clearly indicates the device's role in the diagnostic process.
No
The device description explicitly states it is "Operating System Software" for an "MR system," which is an imaging device. The modification is to a parameter within the software that controls a hardware limitation (SAR limit) of the MR system. The document also discusses image processing techniques used in conjunction with the MR system's hardware to produce images. This indicates the software is an integral part of a larger hardware system (the MR system) and 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" through "non-invasive" means. It produces images of the internal structure of the body.
- Mechanism: The device uses Magnetic Resonance (MR) to generate images based on the properties of protons within the body. This is an in-vivo imaging technique, not an in-vitro test performed on samples outside the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform tests on such specimens.
The device is a medical imaging system used for diagnostic purposes, but it operates by directly imaging the patient's body, not by analyzing samples in a laboratory setting.
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 (comma separated list FDA assigned to the subject device)
90LNH
Device Description
The STRATIS / MRH-1500 Operating System Software is 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. The Hitachi MRH-1500 and STRATIS MR Devices were originally cleared for marketing with an SAR limit of 0.4 W/kg (K943798, K922846B, and K945386), 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
§ 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
AUG 1 4 1996
Summary
K962048
SUBMITTER INFORMATION: 1.0
- 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
- May 24, 1996 1.3 Date:
DEVICE NAME: 2.0
- Magnetic Resonance Diagnostic Device 2.1
- Classification Name: System, Nuclear Magnetic Resonance Imaging 2.2
510(K)
- 90LNH 2.3 Classification Number:
- Trade/Proprietary Name: 1W/kg SAR (Part of Version 6-05 Operatin System Software 2.4
- 2.5 PREDICATE DEVICE(s):
Hitachi STRATIS with Version 3 Operating System Software Hitachi MRH-1500 with Version 3 Operating System Software
DEVICE DESCRIPTION: 3.0
FUNCTION 3.1
The STRATIS / MRH-1500 Operating System Software is 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 MRH-1500 and STRATIS MR Devices were originally cleared for marketing with an SAR limit of 0.4 W/kg (K943798, K922846B, and K945386), 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