(49 days)
Not Found
No
The document describes a standard MRI system and mentions image processing techniques similar to those used in computed tomography, but does not mention AI, ML, or related terms.
No
The device is described as an "imaging device" and specifically states it "is intended to provide physiological and clinical information" and for "diagnosis determination," indicating it is for diagnostic purposes, not therapeutic.
Yes
The device is an imaging system (MRI) that produces images displaying anatomical structures and physiological information, which can then be used by a trained physician for diagnosis determination.
No
The device description explicitly states it is a "Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet," which is a hardware component.
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" used to obtain "physiological and clinical information" through "non-invasively" produced images. It describes the process of generating images based on the magnetic resonance properties of protons within the body. This is characteristic of an imaging system used for diagnosis based on visual interpretation of internal structures.
- Device Description: The description confirms it's a "Magnetic Resonance Imaging System."
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device operates on the patient's body to produce images.
The information provided aligns perfectly with the description of a medical imaging device, specifically an MRI system, which is distinct from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HHF I 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 any part 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. 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 HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry configuration. It is designed to enhance clinical utility as compared to Open MRI system, building upon the Altaire platform and incorporating the imaging properties of the 1.5T magnet. Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause it to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which is the primary nuclei currently used in MR imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the magnetization vector. When the RF excitation is removed, the protons re-emit RF and return to their original alignment. The rate of relaxation is exponential and the protons return to their original alignment based on the character of the proton and its adjacent molecular environment. This re-emission will have characteristic exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation and by varying the magnetic field strength via magnetic gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the these emissions can be reconstructed by using image processing techniques similar to those used in computed tomography. MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 characteristics, contribute to image contrast. By varying magnetic field gradients and RF characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hitachi Altaire MRI System (K050602)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 7 2005
Section 2
510(k) Summary of Safety and Effectiveness
1
Submitter Information 1.0
| 1.1 | Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 425-1410 |
|-----|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| 1.2 | Contact: | Douglas J. Thistlethwaite |
- 8/1/05 1.3 Date:
Device Name 2.0
| 2.1 Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|---|---|
| 2.2 Classification Number: | 90LNH |
| 2.3 Trade/Proprietary Name: | HHF1 Magnetic Resonance Imaging System |
| 2.4 Predicate Device(s): | Hitachi Altaire MRI System (K050602) |
Device Intended Use 3.0
The MR system is an imaging device and is intended to provide the physician with The Mrs system is an maging do rise anbrained non-invasively and without the use of physiological and chilical information, obtailed is as thansverse, coronal, sagittal, oblique, and fonizing radiation. The NH system produces anternal structure of the head, body, or curved cross-scenonal images that =2.p.g 1R system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that protons (first of nage appearance are proton density, spin-lattice relaxation time (TI), spindetermine the miage appearance are promic eented by a trained physician, these images provide information that can be useful in diagnosis determination.
2
Device Description 4.0
4.1 Function
The HHF1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla The First I is a Magnetic Resolunce antinging and based on the Altaire superconducting magnet in an open ganaly coorgined to enhance clinical utility as compared to Open MRT system. The imaging properties of the imaging properties of the 1.5T magnet.
4.2 Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have Magnetic resolutice magniz (1112) is an to act as small spinning bar magnets. The most electionaglicit propertios that bases it the primary nuclei currently used in ubiquitous of these nacier is nydrogen, which a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization nector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength vecific to the magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, cause a re-onemation of the magnetiation vor. The rate of relaxation is exponential and the prototts than and retaril to their originand its adjacent molecular environment. This revalles will the character of the provential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three elimensional matrix. Spatial localization is encoded into the echoes by varying the RF unnensional mattin. Spatial locallents in the x, y, and z directions, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial changing the direction and strenger of sean be reconstructed by using image processing techniques similar to those used in computed tomography.
4.3 Physical and Performance Characteristics
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are loifferent from those responsible for x-ray image contrast. In MR imaging, difference in different noin those responsible for in ag ming and contribute to image proton delisity, blood now, and 11 anse characteristics, the resulting images can emphasize TI, T2, proton density, or the molecular diffusion of water or other proton containing molecules.
3
Device Technological Characteristics 5.0
The technological characteristics of this device are similar to the primary predicate I he tcembological enaracteribles of the 1.5 Tesla superconducting magnet. The control and image processing hardware and the base elements of the system software are identical to the predicate device.
Conclusions 6.0
It is the opinion of Hitachi Medical Systems America, Inc. that HHF1 MRI system is it is the opinion of Intellisted predicate device. The intended use is identical to the listed predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K052172 Trade/Device Name: HHF1 MRDD, w/V1.0 Operating System Software Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 1, 2005 Received: August 9, 2005
Dear Mr. Thistlewaite:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becaled by equivalent (for the indications for use stated in above and nave determined the ac redicate devices marketed in interstate commerce prior to the enclosure) to regally mancede production in the Medical Device Amendments, or to devices that have been May 20, 1770, the chaoinent acte of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general contons provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is olassilied (500 such additional controls. Existing major regulations affecting your Apploval), it thay be subject to basil adains Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I Toase or devisou that 1 Driver that your device complies with other requirements of the Act or any FDA has made a decemination that your as a ministered by other Federal agencies. You must comply with all the I cut at statues and regulations administed to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 Crici Cric Part 820); and if applicable, the electronic product radiation control provisions . (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceling your device of your device to a legally premarket notification. The PDA Intentig of substantial of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device on our labeling org the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation childer, "Wisonaining on your responsibilities under the Act from the 180 807.97). You may obtain other general information your of your of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
长05 2172 510(k) Number (if known): HHF1 MRDD, w/V1.0 Operating System Software Device Name:
Indications for Use:
Indications for USC.
The HHF I MR system is an imaging device, and is intended to provide the use of ion I he HHF I MK system is an maging de nee, and is non-invasively and without the use of ionizing physiological and cinical information, obtained notital, oblique, and curved crossradiation. The MR system produces transverse, coronal, sand had as assessmities. The radiation. The MK system produces thansverse, contine thead, body, or extremities. The sectional images that display the methal structure of any of protons (hydrogen nuclei)
images produced by the MR system reflect the spatial distribution of protons arc mages produced by the MR System reneve the spance that determine the image appearance are
exhibiting magnetic resonance. The NMR properties that determine time (T2), and flo exhibiting magnetic resoliatics. The Nink properates spin relaxation time (T2), and flow.
proton density, spin-lattice relaxation time (T1), spin-spin relaxation that segment proton density, spin-latice relaxation inne (11), spill spill spin relation that can be useful in diagnosis determination.
| Anatomical Region: | Head, Body, Spine, Extremities |
|---|---|
| Nucleus excited: | Proton |
| Diagnostic uses: | T1, T2, proton density weighted imaging |
| Diffusion weighted imaging | |
| MR Angiography | |
| Image processing |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Bergdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _