← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K992650

# AIRIS, AIRIS II (K992650)

_Hitachi Medical Systems America, Inc. · MOS · Oct 8, 1999 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K992650

## Device Facts

- **Applicant:** Hitachi Medical Systems America, Inc.
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Oct 8, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## 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.

## Device Story

The PA/QD Shoulder Coil is an accessory for Hitachi AIRIS and AIRIS II MRI systems. It functions as an RF coil to capture magnetic resonance signals from the shoulder and other large joints. The coil operates in quadrature mode (AIRIS/AIRIS II) or phased array mode (AIRIS II only). It is available in standard and large sizes to optimize coil filling factors. The device does not require software revisions for the host MRI system. It is used in clinical settings by trained physicians to obtain non-invasive, cross-sectional anatomical images. The output is interpreted by physicians to assist in diagnosis and guide minimally invasive procedures. The coil enhances clinical utility by providing specialized imaging for shoulder anatomy.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

RF coil for MRI; available in quadrature and phased array modes; standard and large sizes; compatible with Hitachi AIRIS and AIRIS II systems; ACR/NEMA/DICOM 3 compliant; non-invasive; operates within existing MRI magnetic field and RF pulse parameters.

## Regulatory 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).

## Special Controls

*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.

## Predicate Devices

- Hitachi AIRIS ([K980691](/device/K980691.md))
- Hitachi AIRIS II ([K984278](/device/K984278.md))

## Submission Summary (Full Text)

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992650

OCT 8 1999

## Attachment 1

# 510(k) Summary of Safety and Effectiveness

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#### SUBMITTER INFORMATION: 1.0

| 1.1 | Submitter:              | Hitachi Medical Systems America<br>1959 Summit Commerce Park<br>Twinsburg, OH 44087<br>PH: 330 425-1313<br>FX: 330 425-1410 |
|-----|-------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 1.2 | Contact:                | James Jochen Rogers                                                                                                         |
| 1.3 | Date:                   | August 5, 1999                                                                                                              |
| 2.0 | <b>DEVICE NAME:</b>     |                                                                                                                             |
| 2.1 | Classification Panel:   | Radiology                                                                                                                   |
| 2.2 | Classification Number:  | 892.1000 Magnetic Resonance Diagnostic Device                                                                               |
| 2.3 | Product Nomenclature:   | System, Nuclear Magnetic Resonance Imaging                                                                                  |
| 2.4 | Product Code(s):        | 90LNH<br>90MOS (Magnetic Resonance Specialty Coil)                                                                          |
| 2.5 | Trade/Proprietary Name: | AIRIS, AIRIS II                                                                                                             |
| 2.6 | PREDICATE DEVICE(s):    | Hitachi AIRIS, AIRIS II                                                                                                     |

#### DEVICE DESCRIPTION: 3.0

- FUNCTION 3.1
Identical to the AIRIS 510(k) K980691. Identical to the AIRIS II 510(k) K984278.

The AIRISand AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Coil) to increase the clinical utility of the AIRIS and AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II, and in the quadrature mode only with the AIRIS. The coil is available in Large and Standard sizes for both MRI systems, to accommodate a wide variety of physical patient sizes, and to achieve maximal coil filling factors. Part numbering is as follows:

| MRI System | Imaging Mode | Coil Size | Part Number |
|------------|--------------|-----------|-------------|
| AIRIS II   | Phased Array | Standard  | MR-PSC-51   |
|            | Phased Array | Large     | MR-PSC-52   |
|            | Quadrature   | Standard  | MR-QSC-51   |
|            | Quadrature   | Large     | MR-QSC-52   |
| AIRIS      | Quadrature   | Standard  | MR-QSC-51   |
|            | Quadrature   | Large     | MR-QSC-51   |

AIRIS and AIRIS II software did not need to be revised in order to support full functionality of this PA/QD Shoulder Coil.

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#### 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.

#### 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, 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.

{3}------------------------------------------------

- Head, Body, Spine, Extremities Anatomical Region:
- . Proton Nucleus excited:
- . Diagnostic uses:
	- 2D T1- / T2-weighted imaging T1, T2, proton density measurements
	- MR Angiography
		- image processing
- · Imaging capabilities:
- 2D Spin Echo (SE); also with rephase
- 2D Gradient Field Echo (GE); also with rephase (2D GR)
- 2D Steady state acquisition with rewinded GE (SARGE);
	- also with RF spoiling, rephasing
- 2D Inversion Recovery (IR)
- 2D Fast Spin Echo (FSE); also with rephase
- 2D Fast Inversion Recovery (FIR)
- 2D Dual Slice acquisition (SEDS)
- 3D Spin Echo (SE)
- 3D Gradient Field Echo (GE)
- 3D Steady state acquisition with rewinded GE (SARGE); also with RF spoiling, rephasing
- MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)
- MR Fluoroscopy
- RF Coil Uniformity
- Adaptive Image post-processing
- ACR/NEMA/DICOM 3 compliant
- Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

#### DEVICE TECHNOLOGICAL CHARACTERISTICS: 5.0

Identical to the Predicate Device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 8 1999

James Jochen Rogers Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087

Re:

K992650 PA/QD Shoulder Coil for Airis and Airis II Dated: August 5, 1999 Received: August 6, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Rogers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K992650 510(k) Number (if known): _

## Device Name: Additional RF Coil for AIRIS, AIRIS II (PA/QD Shoulder Coil)

### Indications for Use:

The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.

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 When interpreted by a trained physician, these images provide relaxation time (T2), and flow. information that can be useful in diagnosis determination.

- Head, Body, Spine, Extremities Anatomical Region: Nucleus excited: Proton Diagnostic uses:
- Diagnostic uses:

2D T1- / T2-weighted imaging T1. T2, proton density measurements MR Angiography image processing

- Imaging capabilities:
- 2D, 3D Spin Echo (SE)
- 2D, 3D Fast Spin Echo (FSE)
- 2D Inversion Recovery (IR)
- 2D. 3D Fast Inversion Recovery (FIR)
- 2D,3D Gradient Echo (GE)
- 2D, 3D Steady state acquisition with rewinded GE (SARGE)
- 2D, 3D RF-spoiled SARGE (RSSG)
- 2D, 3D Time-reversed SARGE (TRSG)

MR Angiography (half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)

- 2D, 3D TOF
- 2D, 3D TOF RSSG
- ECG, Peripheral Gating
- RF Coil Uniformity

Adaptive Image post-processing

ACR/NEMA/DICOM 3 compliant

- Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 
(Per 21 CFR 801-109

OR Over-the-Counter Use
/ Semm

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992650

(Optional Format 1-2-96)

---

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