ECHELON Synergy V10.0

K233687 · FUJIFILM Healthcare Americas Corporation · LNH · May 3, 2024 · Radiology

Device Facts

• Record ID: K233687
• Device Name: ECHELON Synergy V10.0
• Applicant: FUJIFILM Healthcare Americas Corporation
• Product Code: LNH · Radiology
• Decision Date: May 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The ECHELON Synergy 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, spinlattice relaxation time (TI), 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

ECHELON Synergy V10.0 is a 1.5T superconducting MRI system. It acquires proton-based MR signals via RF excitation and magnetic field gradients; transforms signals into 3D spatial matrices using image processing techniques similar to CT. Operated by clinicians in clinical settings, the system provides cross-sectional images for diagnostic interpretation. New features include 'DLR Clear' (Deep Learning Reconstruction) for artifact reduction and image enhancement, and 'AutoPose' (Spine, Breast, HipJoint) for automated slice positioning. Output is viewed by physicians to aid clinical decision-making and diagnosis. Benefits include high-quality anatomical imaging without ionizing radiation, improved image sharpness, and reduced scan setup time.

Clinical Evidence

Clinical validation included 53 subjects (9-92 years) across U.S. and Japan. DLR Clear performance was evaluated by 3 board-certified radiologists using 169 images; results showed statistically significant (p<0.05) improvements in truncation artifact reduction, image sharpness, and spatial resolution compared to conventional methods. AutoPose (Spine, Breast, HipJoint) was evaluated by radiological technologists across 308 total cases, demonstrating reduced or equivalent time/steps for slice positioning compared to manual methods. All images were deemed clinically acceptable.

Technological Characteristics

1.5T superconducting magnet, horizontal bore (70cm). Gradient strength 33mT/m, slew rate 130 T/m/sec. RF system: 1 transmitter channel, 32 receiver channels. Standards: NEMA MS 1-5, 8, 14; IEC 60601-1, 60601-1-2, 60601-2-33, 62304. Software includes deep learning-based reconstruction (DLR Clear) and automated positioning (AutoPose).

Indications for Use

Indicated for patients requiring non-invasive diagnostic imaging of the head, body, spine, and extremities using proton-based magnetic resonance. Diagnostic uses include T1, T2, and proton density weighted imaging, diffusion weighted imaging, MR Angiography, spectroscopy, and whole-body imaging.

Regulatory Classification

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

• ECHELON Synergy MRI system (K223426)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2024

Fujifilm Healthcare Americas Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 81 Hartwell Ave Suite 300 Lexington, Massachusetts 02421

Re: K233687

Trade/Device Name: ECHELON Synergy V10.0 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 9, 2024 Received: April 9, 2024

Dear Chaitrali Kulkarni:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D. R. X.

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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### Indications for Use

Submission Number (if known)

#### K233687

Device Name

### ECHELON Synergy V10.0

#### Indications for Use (Describe)

The ECHELON Synergy 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, spinlattice relaxation time (TI), 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:

- · TI, 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)

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K233687

Section 5

510(k) Summary

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| Submitter: | FUJIFILM Healthcare Corporation<br>2-1, Shintoyofuta<br>Kashiwa-shi, Chiba, 277-0804 Japan |
|-------------------|--------------------------------------------------------------------------------------------|
| Contact: | Ms. Kulkarni Chaitrali |
| Telephone number: | 704-517-4886 |
| Telephone number: | 704-517-4886 |
| E-mail: | [e-mail] |
| Date: | November 16, 2023 |

## Subject Device Name

| Trade/Proprietary Name: | ECHELON Synergy V10.0 MRI system |
|-------------------------|--------------------------------------------|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |

## Predicate Device Name

| Predicate Device(s): | ECHELON Synergy MRI system (K223426) |
|----------------------|--------------------------------------------|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | System, Nuclear Magnetic Resonance Imaging |
| Product Code | LNH |
| Class | 2 |
| Panel | Radiology |

## Device Intended Use

The ECHELON Synergy 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

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## Device Description

### Function

The ECHELON Synergy is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design.

### 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 maqnetic 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 varving 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

The ECHELON Synergy V10.0 MRI System is equivalent to the ECHELON Synergy MRI System (K223426) with following exceptions:

- Camera unit is added for Synergy Vision and Visual StillShot.
- . Alternative super-conducting magnet and units related to alternative super-conducting magnet are added.
- . Application software is changed to V10.0A.

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

| Testing Type | Rationale Analysis |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing - Bench | Performance bench testing was conducted on the applicable new feature.<br>Test data confirmed that new feature perform as intended for diagnostic use. |
| Performance Testing - Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical<br>usability. |

Table 1 Performance Analysis

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## 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 Synergy V10.0 MRI system software is substantially equivalent to the ECHELON Synergy MRI System (K223426). See tables below. The technological characteristics in regard to hardware of the ECHELON Synergy V10.0 MRI system and the predicate are listed in Table 2.

| Table 2 Comparison: Hardware | | | | |
|------------------------------|-------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------|
| ITEM | | PREDICATE DEVICE<br>ECHELON SYNERGY MRI SYSTEM<br>(K223426) | SUBJECT DEVICE<br>ECHELON Synergy V10.0 | DIFFERENCE |
| System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 14,<br>IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 14,<br>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 | 63.86MHz | 63.86MHz | No |
| | Bore dimension | Circle shape with diameter 70cm | Circle shape with diameter 70cm | No |
| Gradient System | Gradient Strength | 33mT/m | 33mT/m | No |
| | Slew Rate | 130 T/m/sec | 130 T/m/sec | No |
| | Rise Time | 254µsec to 33mT/m | 254µsec to 33mT/m | No |
| Audible Noise (MCAN) | Ambient | 59.9 dBA | 59.9 dBA | No |
| | Lpeak | 122.7 dBA | 122.7 dBA | No |
| | Leq | 116.5 dBA | 116.5 dBA | No |
| RF System | Transmitter channels | 1 | 1 | No |
| | Peak Envelop Power | 18 kW | 18 kW | No |
| | Duty Cycle | 85% (Gating max), 10% at full power | 85% (Gating max), 10% at full power | No |
| | RF receiver channel | 32 | 32 | No |

Table 2 Comparison: Hardware

The hardware differences from the predicate device to the ECHELON Synerqy V10.0 MRI System are analyzed in Table 3.

| | Table 3 Hardware Comparison Analysis | |
|--|--------------------------------------|--|
| | | |

| FDA<br>Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not<br>constitute a new intended use; and any differences in technological characteristics are accompanied by information that<br>demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and<br>effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see<br>section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| Device<br>Modification<br>Summary | • Camera unit is added for Synergy Vision and Visual StillShot.<br>• Alternative super-conducting magnet and units related to alternative super-conducting magnet are added. The device<br>is changed but there are no significant changes in technology, engineering and performance. | | | |
| Significant<br>Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM<br>Rationale<br>Statement | Modified specification doesn't constitute a new intended use. There are no significant changes in technological<br>characteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELON<br>Synergy MRI System (K223426). So, safety and effectively of the device are same as ECHELON Synergy MRI System<br>(K223426). | | | |

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The technological characteristics in regards to coils of the ECHELON Synergy V10.0 MRI System and the predicate are listed in Table 4.

| ITEM | | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE |
|----------|----------------|---------------------------------------------------|---------------------------------------------------|------------|
| | | ECHELON SYNERGY MRI SYSTEM<br>(K223426) | ECHELON Synergy V10.0 | |
| RF Coils | Transmit Coil | T/R Body | T/R Body | No |
| | Receiver Coils | FlexFit Neuro Coil | FlexFit Neuro Coil | No |
| | | FlexFit Blanket Coil A,<br>FlexFit Blanket Coil B | FlexFit Blanket Coil A,<br>FlexFit Blanket Coil B | No |
| | | Extremity Coil | Extremity Coil | No |
| | | Hand/Wrist Coil | Hand/Wrist Coil | No |
| | | Breast Coil<br>Breast Support Kit 2 | Breast Coil<br>Breast Support Kit 2 | No |
| | | Micro Coil A,<br>Micro Coil B | Micro Coil A,<br>Micro Coil B | No |
| | | Shoulder Coil | Shoulder Coil | No |
| | | Spine Coil | Spine Coil | No |
| | | Foot/Ankle Coil | Foot/Ankle Coil | No |
| | | Flex M Coil, Flex S Coil | Flex M Coil, Flex S Coil | No |

| | Table 4 Comparison: RF Coils | |
|--|------------------------------|--|
|--|------------------------------|--|

The coil differences from the predicate device to the ECHELON Synergy MRI system are analyzed in Table 5.

| Table 5 Coil Comparison Analysis | | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| FDA<br>Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not<br>constitute a new intended use; and any differences in technological characteristics are accompanied by information that<br>demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and<br>effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see<br>section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). | | | |
| Device<br>Modification<br>Summary | There are no differences from the predicate device. | | | |
| Significant<br>Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM<br>Rationale<br>Statement | There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as ECHELON Synergy MRI System (K223426). | | | |

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### The technological characteristics in regard to changes in functionality of the ECHELON Synergy V10.0 MRI System as compared to the predicate are listed in Table 6.

| ITEM | DIFFERENCES | ANALYSIS |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Operating System | None | No |
| CPU Platform | None | No |
| Application Software | Going from V9.0A to V10.0A | See Table 7 |
| Scan Tasks | Following function is updated.<br>- Auto Voice<br>Following positioning applications are added.<br>- AutoPose Breast, AutoPose HipJoint<br>Following positioning application is updated.<br>- AutoPose Spine<br>Following function is added.<br>- Series Save | See Table 7 |
| 2D Processing Tasks | None | No |
| 3D Processing Tasks | None | No |
| Analysis Tasks | None | No |
| Maintenance Tasks | None | No |
| Viewport Tools | None | No |
| Film, Archive Tools | None | No |
| Network Tools | Following Network Tools are added.<br>- AutoProtocol | See Table 7 |
| Protocol Enhancements | Following function is updated.<br>- Delayed Enhancement Imaging<br>- Navi slice positioning<br>- BeamNavi<br>Following variation of Protocol Enhancements are added in Auto Table Centering.<br>- Chest, Breast, General Abdomen, Liver/Kidney, Pelvis, WholeBody<br>Following Protocol Enhancements are added.<br>- Navigated StillShot<br>- Visual StillShot<br>- MROC<br>- IQ Retouch<br>- Exp.RAPID<br>- DWI HD<br>- DLR Clear<br>2D RADAR sequence is added to the applicable sequence of DLR Rise.<br>3D sequences and 2D RADAR are added to the applicable sequence of IterativeRAPID.<br>VASC-FSE is modified. | See Table 7 |
| Pulse Sequences | None | No |
| Monitoring Tools | Following function is added. | See Table 7 |

Table 6 Comparison: Functionality

#### The functionality differences from the predicate device to the ECHELON Synergy V10.0 MRI System are analyzed in Table 7.

#### Table 7 Functionality Comparison Analysis

| FDA<br>Requirements | Analyze why any differences between the subject device and predicate(s) do not render the device NSE (e.g., does not<br>constitute a new intended use; and any differences in technological characteristics are accompanied by information that<br>demonstrates the device is as safe and effective as the predicate and do not raise different questions of safety and<br>effectiveness than the predicate ), affect safety or effectiveness, or raise different questions of safety and effectiveness (see<br>section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)). |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Modification<br>Summary | · Following function is updated in Scan Tasks.<br>- AutoVoice<br>· Following positioning applications are added in Scan Tasks.<br>- AutoPose Breast, AutoPose HipJoint |

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| | - Following positioning application in Scan Tasks is updated.<br>- AutoPose Spine<br>- Following function is added.<br>- Series Save<br>- Following Network Tool is added.<br>- AutoProtocol<br>- Following variation of Protocol Enhancements are added in Auto Table Centering.<br>- Chest, Breast, General Abdomen, Liver/Kidney, Pelvis, WholeBody<br>- Following function of Protocol Enhancements is updated.<br>- Delayed Enhancement Imaging<br>- Navi slice positioning<br>- BeamNavi<br>- Following Protocol Enhancements are added. | | | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------------------|
| | - Navigated StillShot<br>- Visual StillShot<br>- MROC<br>- IQ Retouch<br>- Exp.RAPID<br>- DWI HD<br>- DLR Clear<br>- Following task is added as "Monitoring Tools".<br>- Synergy Vision<br>- Function name of Deep Learning Reconstruction (DLR) added in ECHELON Synergy MRI System (K223426) is changed<br>DLR Rise. DLR is an abbreviation for Deep Learning Reconstruction.<br>- 2D RADAR is added in "DLR Rise" of Protocol Enhancements.<br>- 3D sequences and 2D RADAR are added in "IterativeRAPID" of Protocol Enhancements.<br>- VASC-FSE of Protocol Enhancements is modified.<br>Application software is changed in V10.0A. | | | |
| Significant<br>Changes | □ Manufacturing Process | □ Labeling | □ Technology | □ Performance |
| | □ Engineering | □ Materials | □ Others | ☑ None (See rationale statement) |
| FUJIFILM<br>Rationale<br>Statement | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics.<br>For safety, pulse sequences are controlled according to the same safety limits as ECHELON Synergy MRI System<br>(K223426). Therefore, safety and effectiveness of the device are the same as ECHELON Synergy MRI System (K223426). | | | |

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## Substantial Equivalence

A summary decision was based on analysis of Table 8.

| Table 8 Rationale Analysis: ECHELON Synergy V10.0 vs. Predicate | |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ITEM | Overall Rationale Analysis |
| Hardware | Modified specification doesn't constitute a new intended use. There are no significant changes in technological<br>characteristics. For safety, gradient system and RF system is controlled according to same regulation as ECHELON Synergy<br>MRI System (K223426). So, safety and effectively of the device are same as ECHELON Synergy MRI System (K223426). |
| Coils | There are no differences regarding receiver coils. |
| Functionality | Modified functions do not constitute a new intended use. There are no significant changes in technological characteristics.<br>For safety, pulse sequences are controlled according to the same safety limits as ECHELON Synergy MRI System<br>(K223426). Therefore, safety and effectiveness of the device are the same as ECHELON Synergy MRI System (K223426) |

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 Synergy V10.0 is considered substantially equivalent to the currently marketed predicate device (ECHELON Synergy MRI System (K223426)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

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## Summary of Non-Clinical Testing

The ECHELON Synergy MRI System was subjected to the following laboratory testing.

- ANSI / AAMI 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 60601-2-33 Edition 3.2 b:2015, medical electrical equipment part 2-33: particular . requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic.
- . IEC 62304 Edition 1.1 2015-06, CONSOLIDATED VERSION medical device software - software life cycle processes.
- . IEC 60601-1-2 Edition 4.0:2014. medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances requirements and tests.

The revisions to the ECHELON Synergy V10.0 MRI System will have no effect on the standards tests, which were conducted on the ECHELON Synergy MRI System (K223426) and included in the original submission.

Therefore, ECHELON Synergy V10.0 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 5-2018, Determination of Slice Thickness in Diagnostic Resonance Imaging .
- NEMA MS 8-2016, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic . Resonance Imaging Systems
- . IEC 60825-1:2014, safety of laser products – part 1: equipment classification and requirements.

## Summary of Clinical Testing

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

The validation results of the new features using machine learning (DLR Clear and AutoPose) were described below.

Performance tests of DLR Clear were conducted by using cylindrical phantom and ACR phantom in terms of truncation artifact reduction, improvement of image sharpness, and improvement of spatial resolution with the sampling patterns of 2D Cartesian, 2D Radial, 3D Rectanqular, and 3D Elliptic. Using metrics of Total Validation, Relative Edge Sharpness, and FWHM (Full Width at Half Minimum) of the line-profile of the holes in the ACR phantom, the phantom testing demonstrated that DLR Clear could reduce the truncation artifact in the image, improve image sharpness, and improve the spatial resolution of image. In addition, three US board certified radiologists reviewed the image quality with DLR Clear in terms of the truncation artifact reduction, image sharpness, spatial resolution of image. The

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images reconstructed with either the conventional method or DLR Clear were randomized, blinded to the reviewers, and compared by the reviewers in terms of image quality metrics (truncation artifact reduction, image sharpness, lesion conspicuity, and overall image quality) using 3-point scale. All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. The 53 unique subjects (patients and volunteers) from U.S. and Japan (Male: 33, Female: 20, Age: 9 - 92 years, BMI:18.9 - 50.5) were scanned in the anatomical regions from brain to ankle in order to provide the test datasets separately from the training and validation datasets using FUJIFILM 1.5T MRI Scanners (ECHELON Smart, ECHELON OVAL, and ECHELON Synergy). The total of 169 images in multiple orientations (axial, sagittal and coronal), multiple dimensions (2D and various contrast weightings (T1-/T2-/T2*-/PD-weighted image with/without Fat saturation. FLAIR, DWI, MRA, MRCP, STIR, and Cine) were obtained for the test dataset by pulse sequences of SE, GE, FSE, FIR, BASG, RSSG, EPI, TOF, and PC. The review results indicated that the truncation artifact reduction, image sharpness, and overall image quality in the images with DLR Clear were superior to those in the conventional images with statistically significant difference (p<0.05). The review results also indicated that the lesion conspicuity in the images with DLR Clear was superior or equivalent to that in the conventional images. All of the images with DLR Clear were evaluated as clinically acceptable by the reviewers. The comparison of the overall image quality between the high-resolution images with DLR Clear and the low-resolution images without DLR Clear was also performed by the radiologists. The pairs of the high-resolution images with DLR Clear and the low-resolution images without DLR Clear, reconstructed from the same acquired data, were prepared from the test dataset. All images used for this comparison were evaluated by the radiologists in terms of clinical acceptability. The review results indicated that the overall image quality in the high-resolution images with DLR Clear were superior to that in the low-resolution images without DLR Clear with statistically significant difference and were clinically acceptable. In conclusion, the phantom testing and the clinical Image testing demonstrated that DLR Clear could reduce the truncation artifact in the image, improve image sharpness, and generate higher spatial resolution images from lower resolution images.

The performance tests of AutoPose Spine, Breast and HipJoint, were conducted by the certified radiological technologists. They evaluated that almost cases in AutoPose Spine, Breast, and HipJoint, were able to reduce the time and number of steps in the slice positioning compared to the manual slice positioning. They also evaluated that the remaining cases of AutoPose Spine, Breast, and HipJoint were able to show the same time and number of steps as the manual slice positioning. The information on the data in the above evaluations is shown below.

| | Spine | Breast | HipJoint |
|-----------------------|---------------------------------------------------|--------|----------|
| Data acquisition site | FUJIFILM Healthcare Corporation and clinical site | | |
| Subject type | Healthy volunteer and patients | | |
| Number of cases | 177 | 66 | 65 |

As a result of the analysis:

| Testing Type | Rationale Analysis |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing –<br>Clinical | Clinical image examples are provided for applicable new feature and that we judged to be sufficient to evaluate clinical usability. |

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# Conclusions

The ECHELON Synergy V10.0 MRI system is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON Synergy MRI System (K223426).