APERTO Lucent MRI System
Device Facts
| Record ID | K253862 |
|---|---|
| Device Name | APERTO Lucent MRI System |
| Applicant | Fujifilm Corporation |
| Product Code | LNH · Radiology |
| Decision Date | Apr 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
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.
Device Story
APERTO Lucent is a 0.4 Tesla permanent magnet MRI system. It uses RF excitation and magnetic field gradients to manipulate hydrogen proton magnetization vectors. Relaxation times (T1, T2) and proton density are measured to generate cross-sectional images (transverse, coronal, sagittal, oblique, curved). The system includes various receiver coils (head, body, joint, knee, wrist, spine, shoulder) to capture signals. Operated by trained clinicians in a clinical setting, the device provides non-invasive anatomical images for diagnostic interpretation. This submission adds three specific receiver coils (QD Flexible Body coil N (M), Joint coil(S), Open Body coil) to the existing platform. No changes to core software, pulse sequences, or processing algorithms were made.
Clinical Evidence
No formal clinical trial. Clinical usability was evaluated via collection and analysis of clinical image examples. A radiologist validated that the images produced using the new coils have acceptable image quality for clinical use.
Technological Characteristics
0.4T permanent magnet; 16.18MHz resonant frequency; 22mT/m gradient strength; 55 T/m/sec slew rate. Complies with NEMA MS 1-5, 8, 14 and IEC 60601-1, 60601-1-2, 60601-2-33, 62304. Connectivity via standard network tools. Software is non-ML based.
Indications for Use
Indicated for diagnostic imaging of head, body, spine, and extremities using T1, T2, proton density weighted imaging, diffusion weighted imaging, and MR Angiography. For use by trained physicians.
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
- APERTO Lucent MRI system (K233629)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 6, 2026
FUJIFILM Corporation
% Chaitrali Kulkarni
Sr. Regulatory Affairs Specialist
Fujifilm Healthcare Americas Corporation
81 Hartwell Ave. Suite 100
Lexington, Massachusetts 02421
Re: K253862
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: December 31, 2025
Received: December 31, 2025
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
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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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 (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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253862 - Chaitrali Kulkarni
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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
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| 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. | K253862 | ? |
| 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 | | |
| 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) | |
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K253862
510(k) Summary
©2023 FUJIFILM Healthcare Americas
APERTO Lucent MRI System
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510(k) Summary
# Submitter Information
| Submitter: | FUJIFILM Corporation
26-30, Nishiazabu 2-chome, Minato-ku,
Tokyo, 106-8620 Japan |
| --- | --- |
| Contact: | Duan Threats |
| Telephone number: | 847-767-4859 |
| E-mail: | duan.threats@hotmail.com |
| Date: | |
# 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 (K233629) |
| --- | --- |
| 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
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APERTO Lucent MRI System
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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. And MR system has the Function of measuring spectroscopy.
## Performance Evaluation
The APERTO Lucent MRI System is equivalent to the APERTO Lucent MRI System (K233629) with following exceptions:
- QD Flexible Body coil N (M) was added.
- Joint coil(S) was added
- Open Body coil was added
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 new feature.
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 usability. In addition, a radiologist validated that the clinical images have acceptable image quality for clinical use. |
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APERTO Lucent MRI System
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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 (K233629). 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 | SUBJECT DEVICE | DIFFERENCE | |
| --- | --- | --- | --- | --- |
| | | APERTO LUCENT (K233629) | | APERTO LUCENT |
| 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 new 3 receiver coils (Joint coil(S), QD Flexible Body coil N (M), Open Body coil) are added to APERTO Lucent MRI system. But there are no significant changes in technology, engineering and performance. | | | |
| Significant Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) |
| FUJIFILM Rationale Statement | Added coils don't constitute a new intended use. There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as APERTO Lucent (K233629). | | | |
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APERTO Lucent MRI System
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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 (K233629) | | APERTO LUCENT |
| RF Coils | Receiver Coils | QD Head coil R | QD Head coil R | No |
| | | N/A | QD Flexible Body coil N (M) | Yes |
| | | QD Flexible Body coil N (L) | QD Flexible Body coil N (L) | No |
| | | N/A | Joint coil(S) | Yes |
| | | Joint coil(M) | Joint coil(M) | No |
| | | Joint coil(L) | Joint coil(L) | No |
| | | QD Knee coil R | QD Knee coil R | No |
| | | N/A | Open Body coil | Yes |
| | | 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 | Added the following coils.
- QD Flexible Body coil N (M)
- Joint coil(S)
- Open Body coil | | | |
| Significant Changes | ☐ Manufacturing Process | ☐ Labeling | ☐ Technology | ☐ Performance |
| | ☐ Engineering | ☐ Materials | ☐ Others | ☑ None (See rationale statement) |
| FUJIFILM Rationale Statement | Added coils don't constitute a new intended use. There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as APERTO Lucent (K233629). | | | |
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APERTO Lucent MRI System
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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 | None | No |
| Scan Tasks | None | No |
| 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 | None | No |
| Protocol Enhancements | None | No |
| Pulse Sequences | None | No |
| Powered by Machine Learning | None | No |
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 | 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. 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 (K233629). | | | |
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APERTO Lucent MRI System
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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 | There are no differences regarding hardware units. |
| Coils | Added coils don't constitute a new intended use. There are no significant changes in technological characteristics. Therefore, safety, intended use and effectively of the RF coils are same as APERTO Lucent (K233629). |
| Functionality | There are no differences regarding software functionality. |
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 (K233629)) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
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APERTO Lucent MRI System
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510(k) Summary
# Summary of Non-Clinical Testing
The APERTO Lucent MRI System was subjected to the following laboratory testing.
- IEC60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012+AMD2:2020, Medical electrical equipment - part 1: general requirements for basic safety and essential performance
- 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.
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 (K233629) 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
- IEC 60601-1-2 Edition 4.1:2020, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests.
# Summary of Clinical Testing
Clinical images were collected and analyzed, to ensure that images meet user needs.
As a result of the analysis:
| Testing Type | Rationale Analysis |
| --- | --- |
| Performance Testing - Clinical | Clinical image examples are provided for applicable 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 (K233629).
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APERTO Lucent MRI System
