APERTO Lucent MRI System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 Fujifilm Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Ave. Suite 100 Lexington, Massachusetts 02421 Re: K261283 Trade/Device Name: APERTO Lucent MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: August 14, 2026 Received: August 14, 2026 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261283 - Chaitrali Kulkarni Page 2 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). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 {2} K261283 - Chaitrali Kulkarni Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 Enclosure {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K261283 ? Please provide the device trade name(s). ? APERTO Lucent MRI System Please provide your Indications for Use below. ? The APERTO Lucent 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 - Whole Body Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) ? {4} K261283 ## 510(k) Summary ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 1 of 10 {5} 510(k) Summary ## Submitter Information | Submitter: | FUJIFILM Corporation 26-30, Nishiazabu 2-Chome Minato-ku, Tokyo, 106-8620 Japan | | --- | --- | | Contact: | Ms. Chaitrali Kulkarni | | Telephone number: | 704-517-4886 | | E-mail: | hcusregulatoryaffairs@fujifilm.com | | Date: | April 13, 2026 | ## Subject Device Name | Trade/Proprietary Name: | APERTO Lucent MRI system | | --- | --- | | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | Magnetic resonance diagnostic device | | Product Code | LNH | | Class | 2 | | Panel | Radiology | ## Predicate Device Name | Predicate Device(s): | APERTO Lucent MRI system (K253862) | | --- | --- | | Regulation Number: | 21 CFR 892.1000 | | Regulation Name: | Magnetic resonance diagnostic device | | Product Code | LNH | | Class | 2 | | Panel | Radiology | ## Indications for Use The APERTO Lucent 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 - Whole Body ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 2 of 10 {6} 510(k) Summary ## Device Description ### Function The APERTO Lucent is a Magnetic Resonance Imaging System that utilizes a 0.4 Tesla permanent 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 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. ### Performance Evaluation The APERTO Lucent MRI System is equivalent to the APERTO Lucent MRI System (K253862) with following exceptions: - The storage type of the console is changed from HDD to SSD, and the memory capacity is changed from 16GB to 32GB. - Application software is changed to V11.0C. A rationale analysis was then conducted, and the results are contained in Table 1. Table 1 Performance Analysis | Testing Type | Rationale Analysis | | --- | --- | | Performance Testing - Bench | Performance bench testing was conducted on the applicable feature. Test data confirmed that 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 usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. | ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 3 of 10 {7} 510(k) Summary ## Device Technological Characteristics The control and image processing hardware and the base elements of the system software are identical to the predicate device. The APERTO Lucent MRI system software is substantially equivalent to the APERTO Lucent MRI system (K253862). See tables below. The technological characteristics in regard to hardware of the APERTO Lucent MRI system and the predicate are listed in Table 2. Table 2 Comparison: Hardware | ITEM | | PREDICATE DEVICE APERTO LUCENT (K253862) | SUBJECT DEVICE APERTO LUCENT | DIFFERENCE | | --- | --- | --- | --- | --- | | System | Standards Met | NEMA: MS 1, MS 2, MS 3, MS 4, MS 5, MS 8, MS 14, 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, IEC: 60601-1, 60601-1-2, 60601-2-33, 62304 | No | | Magnet and Gantry | Type and Field Strength | 0.4T Permanent magnet | 0.4T Permanent magnet | No | | | Resonant Frequency | 16.18MHz | 16.18MHz | No | | Gradient System | Gradient Strength | 22mT/m | 22mT/m | No | | | Slew Rate | 55 T/m/sec | 55 T/m/sec | No | | | Rise Time | 400μsec to 22mT/m | 400μsec to 22mT/m | No | | | Audible Noise (MCAN) | | | | | | Ambient | 47.4 dBA | 47.4 dBA | No | | | Lpeak | 104.4 dB | 104.4 dB | No | | | Leq | 91.4 dBA | 91.4 dBA | No | | RF System | Transmitter channels | 4 | 4 | No | | | Peak Envelop Power | 5 kW | 5 kW | No | | | Duty Cycle | 10% square wave | 10% square wave | No | | | RF receiver channel | 2 | 2 | No | The hardware differences from the predicate device to the APERTO Lucent MRI System are analyzed in Table 3. Table 3 Hardware 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** | The storage type of the console is changed from HDD to SSD, and the memory capacity is changed from 16GB to 32GB. | | | | | **Significant Changes** | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance | | | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | | **FUJIFILM Rationale Statement** | There are no significant changes in technological characteristics. For safety, gradient system and RF system is controlled according to same regulation as APERTO Lucent MRI system. So, safety and effectively of the device are same as APERTO Lucent(K253862). | | | | ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 4 of 10 {8} 510(k) Summary The technological characteristics in regards to coils of the APERTO Lucent MRI System and the predicate are listed in Table 4. Table 4 Comparison: RF Coils | ITEM | PREDICATE DEVICE | SUBJECT DEVICE | DIFFERENCE | | | --- | --- | --- | --- | --- | | | | APERTO LUCENT (K253862) | | APERTO LUCENT | | RF Coils | Receiver Coils | QD Head coil R | QD Head coil R | No | | | | QD Flexible Body coil N (M) | QD Flexible Body coil N (M) | No | | | | QD Flexible Body coil N (L) | QD Flexible Body coil N (L) | No | | | | Joint coil(S) | Joint coil(S) | No | | | | Joint coil(M) | Joint coil(M) | No | | | | Joint coil(L) | Joint coil(L) | No | | | | QD Knee coil R | QD Knee coil R | No | | | | Open Body coil | Open Body coil | No | | | | QD Wrist coil | QD Wrist coil | No | | | | C-Spine coil | C-Spine coil | No | | | | QD Head coil (L) | QD Head coil (L) | No | | | | MA Shoulder coil | MA Shoulder coil | No | The coil differences from the predicate device to the APERTO Lucent MRI system 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 | There are no differences from the predicate device. | | | | | Significant Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance | | | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | | FUJIFILM Rationale Statement | There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as APERTO Lucent(K253862). | | | | ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 5 of 10 {9} 510(k) Summary The technological characteristics in regard to changes in functionality of the APERTO Lucent 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 V7.1E to V11.0C | See Table 7 | | Scan Tasks | Following function is modified. - SAR Display - Accumulated SA Warning Following positioning applications are added. - AutoPose Spine, AutoPose Knee, AutoPose Shoulder, AutoPose HipJoint, AutoPose Pelvis for male, AutoPose Pelvis for female | No | | 2D Processing Tasks | None | No | | 3D Processing Tasks | Following function is modified. - Multiplanar Reformatting (MPR) | See Table 7 | | Analysis Tasks | None | No | | Maintenance Tasks | None | No | | Viewport Tools | None | No | | Film, Archive Tools | None | No | | Network Tools | None | No | | Protocol Enhancements | Following Protocol Enhancements are modified. - Gating: cardiac, peripheral pulse, Respiratory Gating Following Protocol Enhancements are added. - IQ Retouch - Clear Level - AutoExam Knee, AutoExam Shoulder - Series Save - DLR Plus - Circular Acquisition | See Table 7 | | Pulse Sequences | The use of Half Scan ON+ is expanded in the following Pulse Sequences. - 2D Spin Echo (2D SE), 2D Fast Spin Echo (2D FSE), 2D Fast Inversion Recovery (2D FIR), 2D Fast Spin Echo (2D primeFSE), 2D Fast Inversion Recovery (2D primeFIR), 2D Spin Echo Fat Water Separation (2D FATSEPSE), 2D Fast Spin Echo Fat Water Separation (2D FATSEPFSE), 2D Gradient Echo(2D GE), 2D Steady State Acquisition Rewound Gradient Echo (2D SG), 2D RF Spoiled SARGE (2D RSSG), 2D Balanced SARGE (2D BASG), 2D Phase Balanced SARGE (2D PBSG), 2D Gradient Echo Fat Water Separation (2D FATSEPGE), 2D SARGE Fat Water Separation (2D FATSEPSARGE), 2D Spoiled SARGE Fat Water Separation (2D FATSEPRSSG), 3D Gradient Echo(3D GE), 3D Steady State Acquisition Rewound Gradient Echo (3D SG), 3D RF Spoiled SARGE (3D RSSG), 3D Balanced SARGE (3D BASG), 3D Phase Balanced SARGE (3D PBSG), 3D Gradient Echo Fat Water Separation (3D FATSEPGE), 3D SARGE Fat Water Separation (3D FATSEPSARGE), 3D Spoiled SARGE Fat Water Separation (3D FATSEPRSSG) Following Pulse Sequence is added. - 3D isoFSE | See Table 7 | The functionality differences from the predicate device from the APERTO Lucent MRI System are analyzed in Table 7. 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 | Application software is changed to V11.0C. - Following function is modified in Scan Tasks. - SAR Display - Accumulated SA Warning - Following positioning applications are added in Scan Tasks. | ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 6 of 10 {10} 510(k) Summary | | - AutoPose Spine, AutoPose Knee, AutoPose Shoulder, AutoPose HipJoint, AutoPose Pelvis for male, AutoPose Pelvis for female - Following function is modified in 3D Processing Tasks. - Multiplanar Reformatting (MPR) - Following functions of Protocol Enhancements are added. - IQ Retouch - Clear Level - AutoExam Knee, AutoExam Shoulder - Series Save - DLR Plus - Circular Acquisition - The use of Half Scan ON+ is expanded in the following Pulse Sequences. - 2D Spin Echo (2D SE), 2D Fast Spin Echo (2D FSE), 2D Fast Inversion Recovery (2D FIR), 2D Fast Spin Echo (2D primeFSE), 2D Fast Inversion Recovery (2D primeFIR), 2D Spin Echo Fat Water Separation (2D FATSEPSE), 2D Fast Spin Echo Fat Water Separation (2D FATSEPFSE), 2D Gradient Echo(2D GE), 2D Steady State Acquisition Rewound Gradient Echo (2D SG), 2D RF Spoiled SARGE (2D RSSG), 2D Balanced SARGE (2D BASG), 2D Phase Balanced SARGE (2D PBSG), 2D Gradient Echo Fat Water Separation (2D FATSEPGE), 2D SARGE Fat Water Separation (2D FATSEPSARGE), 2D Spoiled SARGE Fat Water Separation (2D FATSEPRSSG), 3D Gradient Echo(3D GE), 3D Steady State Acquisition Rewound Gradient Echo (3D SG), 3D RF Spoiled SARGE (3D RSSG), 3D Balanced SARGE (3D BASG), 3D Phase Balanced SARGE (3D PBSG), 3D Gradient Echo Fat Water Separation (3D FATSEPGE), 3D SARGE Fat Water Separation (3D FATSEPSARGE), 3D Spoiled SARGE Fat Water Separation (3D FATSEPRSSG) - Following Pulse Sequence is added. - 3D isoFSE | | | | | --- | --- | --- | --- | --- | | Significant Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance | | | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) | | FUJIFILM Rationale Statement | | There are no significant changes in technological characteristics. For safety, pulse sequences are controlled according to the same safety limits as APERTO Lucent(K253862). Therefore, safety and effectiveness of the device are the same as APERTO Lucent(K253862). | | | ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 7 of 10 {11} 510(k) Summary ## Substantial Equivalence A summary decision was based on analysis of Table 8. Table 8 Rationale Analysis: APERTO Lucent vs. Predicate | ITEM | Overall Rationale Analysis | | --- | --- | | **Hardware** | The storage type of the console is changed from HDD to SSD, and the memory capacity is changed from 16GB to 32GB. But there are no significant changes in technological characteristics. So, safety and effectively of the device are same as APERTO Lucent MRI System (K253862). | | **Coils** | There are no differences regarding software functionality. | | **Functionality** | Additional functions do not constitute a new intended use. There are no significant changes in technological characteristics. So, safety and effectivity of the device are equivalent to APERTO Lucent MRI System (K253862). | Therefore, based on a thorough analysis and comparison of the functions, scientific concepts, physical and performance characteristics, performance comparison and technological characteristics, the proposed APERTO Lucent is considered substantially equivalent to the currently marketed predicate device (APERTO Lucent MRI System (K253862)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 8 of 10 {12} 510(k) Summary ## Summary of Non-Clinical Testing The APERTO Lucent MRI System was subjected to the following laboratory testing. - IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-2-33 Edition 4.0 2022-08 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. The revisions to the APERTO Lucent MRI System will have no effect on the standards tests, which were conducted on the APERTO Lucent MRI System (K253862) and included in the original submission. Therefore, APERTO Lucent 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 Magnetic 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 ## 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 Plus and AutoPose) were described below. Performance tests of DLR Plus were conducted by using digital and physical phantoms in terms of SNR, truncation artifacts, image sharpness, and image contrast. The phantom testing demonstrated that DLR Plus could reduce noise and truncation artifacts and could improve image sharpness in the image by using the metrics of SNR, Total Variation, and Relative Edge Sharpness. The phantom testing also demonstrated that DLR Plus did not degrade the image quality by using the metric of Contrast Change Rate. In addition, three U.S. board-certified radiologists reviewed the clinical and volunteer images with DLR Plus in terms of the image quality metrics (SNR, truncation artifacts, image sharpness, lesion conspicuity, and overall image quality). The images reconstructed either without or with DLR Plus were randomized, blinded to the reviewers, and compared by the reviewers in terms of the image quality metrics using a 3-point scale. All images used for this comparison were also evaluated by the reviewers in terms of clinical acceptability. The 68 unique subjects (patients and volunteers) from U.S. and ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 9 of 10 {13} 510(k) Summary Japan (Male:37, Female:31, Age:7~89 years, BMI:14.2~42.5) 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 the FUJIFILM 0.4T MRI Scanner (APERTO Lucent). The total of 171 cases in multiple orientations (axial, sagittal, and coronal), multiple dimensions (2D and 3D), and various contrast weightings (T1-/T2-/T2*-/PD-weighted image, FLAIR, DWI, and MRA) were obtained for the test dataset by pulse sequences of SE, FSE, GE, SSFP, DW EPI, TOF, and PC. The test dataset was independent of the training and validation datasets. The review results indicated that all image quality metrics (SNR, truncation artifacts, image sharpness, lesion conspicuity, and overall image quality) in the images with DLR Plus were superior to those in the conventional images with statistically significant differences (p<0.05). Additionally, all images with DLR Plus were evaluated as clinically acceptable by the reviewers. In conclusion, the phantom testing and the clinical image testing demonstrated that DLR Plus could reduce noise and truncation artifacts, could improve image sharpness, and did not degrade the image quality compared to the predicate device. The performance tests of AutoPose Spine, Shoulder, Knee, HipJoint, Pelvis for male, and Pelvis for female were conducted by the three certified radiological technologists. The evaluation results showed that the almost cases in AutoPose Spine, Shoulder, Knee, HipJoint, Pelvis for male, and Pelvis for female were able to set the slice positions for a scan without manual adjustment. The evaluation results also showed that the remaining cases were the same user operation steps as the manual slice positioning as without using AutoPose. The information on the data in the evaluation is shown below. | | Spine | Knee | Shoulder | HipJoint | Pelvis for female | Pelvis for male | | --- | --- | --- | --- | --- | --- | --- | | Number of cases | 112 | 35 | 32 | 32 | 33 | 30 | | Data acquisition site | FUJIFILM Corp., FUJIFILM Healthcare Americas Corp., two clinical sites in U.S. | | | | | FUJIFILM Corp., FUJIFILM Healthcare Americas Corp. | | Subject Type | Healthy volunteer and patients | | | | | Healthy volunteer | As a result of the analysis: | Testing Type | Rationale Analysis | | --- | --- | | Performance Testing - Clinical | Clinical image examples are provided for applicable new feature and that 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 The APERTO Lucent MRI system is substantially equivalent with respect to hardware, software, safety, effectiveness, and functionality to the APERTO Lucent MRI System (K253862). ©2026 FUJIFILM Healthcare Americas APERTO Lucent MRI System Page 10 of 10