Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard MRI system and its features, with no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is described as an "imaging device" used to provide "physiological and clinical information" and produce "images" for "diagnosis determination." It does not mention any therapeutic use.

Diagnostic

Yes
The text states that the images produced by the MR system, "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This indicates its use in diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design, indicating it is a hardware-based imaging system, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body (in vitro).
Device Function: The ECHELON Oval System is a Magnetic Resonance Imaging (MRI) system. It is an imaging device that produces images of the internal structure of the body non-invasively. It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's an "imaging device" that provides "physiological and clinical information, obtained non-invasively." This aligns with the function of an imaging system, not an IVD.

Therefore, based on the provided information, the ECHELON Oval System is a medical imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ECHELON Oval 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

LNH and LNI

Device Description

The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.

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

Physician / 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)

Being the ECHELON Oval V5.0 MRI System is only a software update with new features, a clinical and performance evaluation was conducted on only the new features which include:

ASL-Perfusion
Beam Sat VASC-ASL
Breast MRS
Enhanced PC
Fat and water separation scan (FSE, RSSG. GE)
k-RAPID
Multi b and DKI
opFSE / opFIR
PBSG
RADAR-GE/TOF
T2* RelaxMap

Performance Testing - Clinical: We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use.

Performance Testing - Bench: We generated bench data for each of the new features. We confirmed that each new feature performs as intended for diagnostic use.

Summary of Non-Clinical Testing:

ASL-Perfusion: Test results confirm ASL-Perfusion acquires perfusion images using labeled blood flowing into the brain tissue without Contrast-Enhanced both in phantom simulations and clinical results.
Beam Sat VASC-ASL: Test results confirm Beam Sat improves the visibility of the portal vein in making MIP images both in phantom simulations and clinical results.
Breast MRS: Test results from phantom simulations and clinical results confirm MRS (Magnetic Resonance Spectroscopy) acquires the magnetic resonance signal of in vivo metabolites through chemical shift phenomenon and can detect Choline as metabolite in the breast area.
Enhanced PC: Test results from phantom simulations and clinical results indicate a reduction in scan time of phase contrast (PC) sequence in 2D and 3D by shorting the TR by optimizing velocity encode gradient and applied parallel imaging (RAPID). As a result of this improvement, we can shorten scan time of "4D flow" which is time-resolved (CINE) three-dimensional (3D) spatial encoding combined with three-directional velocityencoded phase contrast MRI.
Fat and water separation scan (FSE, RSSG, GE): Test results from phantom simulations and clinical results indicate reliable and uniform fat suppression by utilizing the difference between resonant frequencies due to chemical shift of water protons and fat protons to obtain a water image and a fat image. The chemical shift of a water signal and a fat signal receives two echo signals at the timing which becomes an in-phase and an out-of-phase. By adding and subtracting it, a water image and a fat image are simultaneously acquirable.
k-RAPID: Test results from phantom simulations and clinical results indicate that k-space parallel imaging technique accelerates the scan by acquiring k-space data with skipped phase encoding and skipped position which is filled with estimated data by the interpolation of neighboring data.
Multi b and DKI: Test results from phantom simulations and clinical results confirm Multi b DKI images can be acquired in one scan utilizing Tensor 15 and Tensor 30 being added to the number of MPG Axes. Diffusion Kurtosis Imaging (DKI) is the diffusion-weighted imaging technique in restriction.
opFSE / opFIR: Test results from phantom simulations and clinical results confirm by deriving opFSE and opFIR sequence from the primeFSE and primeFIR image quality is improved.
PBSG: Test results from phantom simulations and clinical results confirm PBSG which is a sequence based on BASG sequence improves to mitigate the dark band artifact which is unique to BASG sequence. The PBSG sequence makes it possible to acquire BASG images under the condition of inhomogeneous magnetic field with less band artifact.
RADAR-GE/TOF: Test results from phantom simulations and clinical results confirm the RADAR measurement feature is functioning with the GE and TOF sequence.
T2* RelaxMap: Test results from phantom simulations and clinical results confirm that T2* relaxation time can be mapped on morphological image in color by using T2* RelaxMap function. The T2* RelaxMap function consists of (a) acquisition of multi-echo images (up to 32) and (b) analysis of T2* relaxation time.

Summary of Clinical Testing: Clinical images were collected and analyzed, to ensure that images from the new features meet user needs. As a result of the analysis: Performance Testing - Clinical: We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113145

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 29, 2015

Hitachi Medical Systems America, Inc. % Mr. Doug Thistlethwaite Manager of Regulatory Affairs 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K151015

Trade/Device Name: ECHELON Oval V5.0 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LNI Dated: July 1, 2015 Received: July 6, 2015

Dear Mr. Thistlethwaite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: January 31, 2017
Indications for Use	See PRA Statement below.

510(k) Number (if known)	K151015
Device Name	ECHELON OVAL V5.0 MRI system

Indications for Use (Describe)
The ECHELON Oval 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.

Anatomical Region:	Head, Body, Spine, Extremities
Nucleus excited:	Proton
Diagnostic uses:	T1, T2, proton density weighted imaging
Diffusion weighted imaging
MR Angiography
Image processing
Spectroscopy
Whole Body

Type of Use (Select one or both, as applicable)

\ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
----------------------	-------------

3

Section 5

510(k) Summary

4

| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 | | |
|-------------------------|--------------------------------------------------------------------------------------------------|--|--|
| Contact: | Douglas J. Thistlethwaite | | |
| Telephone number: | 330-425-1313 | | |
| Telephone number: | 330-963-0749 | | |
| E-mail: | thistlethwaited@hitachimed.com | | |
| Date: | April 13, 2015 | | |
| Device Name | | | |
| | | | |
| Regulation Number: | 892.1000 | | |
| Requlation Name: | System, Nuclear Magnetic Resonance Imaging | | |
| Product Code | LNH | | |
| Class | 2 | | |
| Panel | Radiology | | |
| Trade/Proprietary Name: | ECHELON Oval V5.0 MRI System | | |

Submitter Information

Device Intended Use

The ECHELON Oval 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.

Anatomical Region: Head, Body, Spine, Extremities

Nucleus excited: Proton

Diagnostic uses:

. T1, T2, proton density weighted imaging
Diffusion weighted imaging ●
MR Angiography ●
Image processing
Spectroscopy
. Whole Body

Device Description

Function

The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.

5

Scientific Concepts

Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance 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 net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two 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, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

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 different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules. And MR system has the Function of measuring spectroscopy.

Performance Evaluation

Being the ECHELON Oval V5.0 MRI System is only a software update with new features, a clinical and performance evaluation was conducted on only the new features which include:

. ASL-Perfusion
. Beam Sat VASC-ASL
Breast MRS ●
Enhanced PC ●
Fat and water separation scan (FSE, ● RSSG. GE)
. k-RAPID
Multi b and DKI ●
opFSE / opFIR ●
PBSG ●
RADAR-GE/TOF
T2* RelaxMap ●

A rationale analysis was then conducted and the results are contained in Table 1.

Table 1 Performance Analysis

Testing Type	Rationale Analysis
Performance Testing - Clinical	We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. In
addition, a radiologist validated that the clinical images have acceptable image quality for clinical use.
Performance Testing - Bench	We generated bench data for each of the new features.
We confirmed that each new feature performs as intended for diagnostic use.

Device Technological Characteristics

The control and image processing hardware and the base elements of the system software are identical to the predicate device. The ECHELON OVAL includes V5.0 software is substantially equivalent to the ECHELON OVAL (K113145). See tables below.

6

The technological characteristics in regards to hardware of the ECHELON Oval V5.0 MRI System and the predicate are listed in Table 2.

| | ITEM | ECHELON OVAL (K113145)
PREDICATE | ECHELON OVAL V 5.0 | DIFFERENCE
ANALYSIS |
|----------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------|
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS
5, MS 8,
IEC: 60601-1, 60601-1-1, 60601-1-2,
60601-1-4, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4,
MS 5, MS 8,
IEC: 60601-1, 60601-1-2, 60601-2-
33, 62304 | No |
| Magnet and
Gantry | Type and Field
Strength | Super-conducting magnet, horizontal
bore, 1.5 Tesla | Super-conducting magnet,
horizontal bore, 1.5 Tesla | No |
| | Resonant
Frequency | 63.86 MHz | 63.86MHz | No |
| Gradient
System | Gradient Strength | 34mT/m | 34mT/m | No |
| | Slew Rate | 150 T/m/sec | 150 T/m/sec | No |
| | Rise Time | 227µsec to 34mT/m | 227 µsec to 34mT/m | No |
| Audible Noise (MCAN) | | | | |
| | Ambient | 56 dBA | 58 dBA | See Table 3 |
| | Lpeak | 121 dBA | 125 dBA | See Table 3 |
| | Leq | 119 dB | 117 dBA | See Table 3 |
| RF System | Transmitter
channels | 2 | 2 | No |
| | Peak Envelop
Power | 40 kW | 40 kW | No |
| | Duty Cycle | 100% (Gating max), 12.5% at full
power | 100% (Gating max), 12.5% at full
power | No |
| | RF receiver
channel | 16 | 16 | No |

Table 2 Comparison: Hardware

The hardware differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in Table 3.

| FDA
Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see
section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| Device
Modification
Summary | There are no significant hardware changes that affect technological characteristics and safety. | | | |
| Significant
Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) |
| HITACHI
Rationale
Statement | Modified specification doesn't constitute a new intended use. There are no significant changes in technological characteristics.
For safety, gradient system and RF system is controlled according to same regulation as ECHELON OVAL (K113145). So,
safety and effectively of the device are same as ECHELON OVAL (K113145) | | | |

7

The technological characteristics in regards to coils of the ECHELON Oval V5.0 MRI System and the predicate are listed in Table 4.

| ITEM | ECHELON OVAL (K113145)
|
-------------------|---------------------------------------------------------------|-------------|
| T/R Body | No |
Posterior/Anterior Head | WIT Posterior Head/Neck coil,
| WIT Torso coil | See Table 5 |
| Extremity coil (Knee) | See Table 5 |
| WIT Anterior Neck attachment | See Table 5 |
Extremity(S) (Hand/Wrist) | Hand/Wrist coil | See Table 5 |
| WIT Anterior NV attachment | See Table 5 |
| Breast | See Table 5 |
| MP coil 140A, B | See Table 5 |
| Shoulder | See Table 5 |
| WIT Spine coil 12 | See Table 5 |
| WIT Spine coil 8 | See Table 5 |
| Foot/Ankle | See Table 5 |
| Flexible Extremity (Long Bone) | See Table 5 |
| WIT Cardiac | See Table 5 |
| PV | See Table 5 |

	Table 4 Comparison: RF Coils

The coil differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in Table 5.

Table 5 Coil Comparison Analysis
FDA
Requirements	Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see
section 513(i)(1)(A) of the FD&C Act and
21 CFR 807.87(f)).
Device
Modification
Summary	Some coil names are changed. The performance and technological characteristics of the coils are the same as ECHELON
OVAL (K113145).
Significant
Changes	□ Manufacturing Process	□ Labeling	□ Technology	□ Performance
	□ Engineering	□ Materials	□ Others	☑ None (See rationale statement)
HITACHI
Rationale
Statement	Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics.
During transmitter coil operation, RF Coils are de-resonated by same scheme as ECHELON OVAL (K113145).

8

The technological characteristics in regards to changes in functionality of the ECHELON Oval V5.0 MRI System as compared to the predicate are listed in Table 6.

Table 6 Comparison: Functionality

ITEM	DIFFERENCES	ANALYSIS
Operating System	None	No
CPU Platform	None	No
Application Software	Going from V4.0A to V5.0A	See Table 7
Scan Tasks	None	No
2D Processing Tasks	Only difference is T2* calculation is now available on ECHELON Oval V5.0.	See Table 7
3D Processing Tasks	None	No
Analysis Tasks	Only change is DEC-FA, AD, RD, MK, AK, RK, and FAK Maps with DWI Analysis are now available on
ECHELON Oval V5.0.	See Table 7
Maintenance Tasks	None	No
Viewport Tools	None	No
Film, Archive Tools	None	No
Network Tools	None	No
Protocol Enhancements	Only change is Multi-b measurement, k-RAPID, T2* Relax Map, BeamSat VASC-ASL, RADAR (2DGE,
3D GE, 2D TOF, and 3D TOF), ASL-Perfusion, Enhanced PC (improvement of Cine PC), and Breast
MRS are now available on ECHELON Oval V5.0.	See Table 7
Pulse Sequences	Only change is 2D Spoiled SARGE Fat Water Separation (2D FATSEPRSSG), 3D Spoiled SARGE Fat
Water Separation (3D FATSEPRSSG), 2D Fast Spin Echo Fat Water Separation (2D FATSEPFSE),
2D Gradient Echo Fat Water Separation (2D FATSEPGE), 3D Gradient Echo Fat Water Separation
(3D FATSEPGE), 2D Fast Spin Echo (2D opFSE), 2D Fast Spin Echo (2D opFIR), 2D Phase Balanced
SARGE (2D PBSG), and 3D Phase Balanced SARGE (3D PBSG) are now available on ECHELON
Oval V5.0.	See Table 7

The functionality differences from the ECHELON Oval V5.0 MRI System to the predicate device are analyzed in

Table 7 Functionality Comparison Analysis

Table 7 Functionality Comparison Analysis
FDA
Requirements	Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not
constitute a new intended use; and any differences in technological characteristics are accompanied by information that
demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and
effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see
section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)).
Device
Modification
Summary	2D Processing Tasks
T2* Calculation - Adds the ability to obtain T2* maps as opposed to previous software. Benefits areas such as liver and
cartilage imaging.
Analysis Tasks
DWI Analysis- New Maps are added and allow for advanced evaluation of diffusion tensor and diffusion kurtosis imaging.
Protocol Enhancements
k-RAPID - K-space based parallel imaging. Reduces the occurrence of wrap artifacts.
T2* RelaxMap - Adds the ability to obtain T2* maps as opposed to previous software. Benefits areas such as liver and
cartilage imaging.
BeamSat VASC-ASL - Cylindrical preset pulse added to current VASC-ASL sequence. Benefit is to selectively saturate a
target vascular structure.
ASL-Perfusion - Non-contrast brain perfusion. pASL based gradient echo EPI sequence.
Enhanced PC - Reduces minimum TR/TE and adds RAPID capability.
Breast MRS - Added single voxel breast spectroscopy
Multi-b measurement - Gives the ability to acquire more than one B factor in one scan which saves time with no change in
image quality.
RADAR - 2D/3D GE and 2D/3D TOF pulse sequences can now use RADAR motion correction.

9

	Pulse Sequences
	2D/3D FatSepRSSG - TE can be adjusted as opposed to a fixed TE in the previous software. Single 2pt. was added which
gives the benefit of higher resolution scans.
	2D FatSepFSE - Inner Echo time is now adjustable as opposed to the previous version of software. Single 2pt. was added
which gives the benefit of higher resolution scans.
	2D/3D FatSepGE - New, allows for T2* weighted imaging.
	2D opFSE - Improved SNR, less artifacts, makes images less grainy than conventional FSE.
2D opFIR - Improved SNR, less artifacts, makes images less grainy than conventional FIR.
	2D/3D PBSG - BASG sequence acquired at two different RF phases, resulting in decreased banding artifacts.
Significant
Changes	☐ Manufacturing Process	☐ Labeling	☐ Technology	☐ Performance
	☐ Engineering	☐ Materials	☐ Others	☑ None (See rationale statement)
HITACHI
Rationale
Statement	Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics. For
safety, pulse sequences are controlled according to same safety limits as ECHELON OVAL (K113145). So safety and
effectivity of the device are equivalent to the ECHELON OVAL (K113145).

Substantial Equivalence

A summary decision was based on analysis of Table 8.

Table 8 Rationale Analysis: ECHELON Oval V5.0 MRI vs. Predicate

ITEM	Overall Rationale Analysis
Hardware	Different specifications do not constitute a new intended use. There are no significant changes in technological
characteristics, safety and effectiveness.
Coils	Modified functions don't constitute a new intended use. There are no significant changes in technological characteristics,
safety and effectiveness.
Functionality	Enhanced features do not constitute a new intended use. There are no significant changes in technological characteristics,
safety and effectiveness. The feature set of the device is generally equivalent to the Predicate.

Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed ECHELON Oval V5.0 MRI is considered substantially equivalent to the currently marketed predicate device (ECHELON Oval MRI System (K113145)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

10

Summary of Non-Clinical Testing

The revisions to the ECHELON Oval V5.0 MRI System software will have no effect on the standards tests which were conducted on the ECHELON Oval MRI System (K113145) and included in the original submission.

Therefore, ECHELON Oval V5.0 MRI System is in conformance with the applicable parts of the following standards:

NEMA MS 1-2008. Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images
. NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images ●
NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices
NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging ●
. NEMA MS 8-2008. Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012. c1:2009/(r) 2012 and a2:2010/(r ) 2012 ● (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
. IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests.
IEC 60601-2-33 Edition 3.1 2013-04, medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
IEC 62304 First edition 2006-05, medical device software software life cycle processes. .

In addition, tests were conducted on the new features of the ECHELON Oval V5.0 MRI System, they include:

ASL-Perfusion .

Test results confirm ASL-Perfusion acquires perfusion images using labeled blood flowing into the brain tissue without Contrast-Enhanced both in phantom simulations and clinical results.

Beam Sat VASC-ASL ●

Test results confirm Beam Sat improves the visibility of the portal vein in making MIP images both in phantom simulations and clinical results.

Breast MRS ●

Test results from phantom simulations and clinical results confirm MRS (Magnetic Resonance Spectroscopy) acquires the magnetic resonance signal of in vivo metabolites through chemical shift phenomenon and can detect Choline as metabolite in the breast area.

● Enhanced PC

Test results from phantom simulations and clinical results indicate a reduction in scan time of phase contrast (PC) sequence in 2D and 3D by shorting the TR by optimizing velocity encode gradient and applied parallel imaging (RAPID). As a result of this improvement, we can shorten scan time of "4D flow" which is time-resolved (CINE) three-dimensional (3D) spatial encoding combined with three-directional velocityencoded phase contrast MRI.

11

Fat and water separation scan (FSE, RSSG, GE) ●

Test results from phantom simulations and clinical results indicate reliable and uniform fat suppression by utilizing the difference between resonant frequencies due to chemical shift of water protons and fat protons to obtain a water image and a fat image. The chemical shift of a water signal and a fat signal receives two echo signals at the timing which becomes an in-phase and an out-of-phase. By adding and subtracting it, a water image and a fat image are simultaneously acquirable.

k-RAPID .

Test results from phantom simulations and clinical results indicate that k-space parallel imaging technique accelerates the scan by acquiring k-space data with skipped phase encoding and skipped position which is filled with estimated data by the interpolation of neighboring data.

Multi b and DKI .

Test results from phantom simulations and clinical results confirm Multi b DKI images can be acquired in one scan utilizing Tensor 15 and Tensor 30 being added to the number of MPG Axes. Diffusion Kurtosis Imaging (DKI) is the diffusion-weighted imaging technique in restriction.

opFSE / opFIR .

Test results from phantom simulations and clinical results confirm by deriving opFSE and opFIR sequence from the primeFSE and primeFIR image quality is improved.

PBSG .
Test results from phantom simulations and clinical results confirm PBSG which is a sequence based on BASG sequence improves to mitigate the dark band artifact which is unique to BASG sequence. The PBSG sequence makes it possible to acquire BASG images under the condition of inhomogeneous magnetic field with less band artifact.

RADAR-GE/TOF .

Test results from phantom simulations and clinical results confirm the RADAR measurement feature is functioning with the GE and TOF sequence.

T2* RelaxMap .

Test results from phantom simulations and clinical results confirm that T2* relaxation time can be mapped on morphological image in color by using T2* RelaxMap function. The T2* RelaxMap function consists of (a) acquisition of multi-echo images (up to 32) and (b) analysis of T2* relaxation time.

12

Summary of Clinical Testing

Clinical images were collected and analyzed, to ensure that images from the new features meet user needs.

As a result of the analysis:

Testing Type	Rationale Analysis
Performance Testing - Clinical	We provide clinical image examples for each new feature and we judged to be sufficient to evaluate clinical usability. In
addition, a radiologist validated that the clinical images have acceptable image quality for clinical use.

Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. the ECHELON Oval V5.0 MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON Oval MRI System (K113145).