Who is the manufacturer of MAGNETOM Free.Max?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MAGNETOM Free.Max (K210611).

What is the FDA product code for MAGNETOM Free.Max?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MAGNETOM Free.Max?

510(k) clearance (submission type: Traditional).

Does MAGNETOM Free.Max use AI or machine learning?

Yes. MAGNETOM Free.Max (K210611) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like MAGNETOM Free.Max?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like MAGNETOM Free.Max get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

MAGNETOM Free.Max

K210611 · Siemens Medical Solutions USA, Inc. · LNH · Jul 1, 2021 · Radiology

Device Facts

Record ID	K210611
Device Name	MAGNETOM Free.Max
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	LNH · Radiology
Decision Date	Jul 1, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML

Intended Use

The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.

Device Story

MAGNETOM Free.Max is an 80 cm bore, 0.55T superconducting MRI system. It acquires MR signals to produce cross-sectional images (transverse, sagittal, coronal, oblique) and derived physical parameters of head, body, and extremities. Operated by trained healthcare professionals in clinical settings. Features include myExam Companion (3D camera, cockpit, assist, autopilot) for workflow guidance and patient setup. Employs advanced software (syngo MR XA40A) for image reconstruction, denoising (Deep Resolve Gain), and sharpness enhancement (Deep Resolve Sharp). Output is interpreted by physicians to assist in clinical diagnosis. Benefits include improved patient access via 80cm bore and optimized workflow via automated positioning and guidance.

Clinical Evidence

Bench testing only. Included image quality assessments, SNR/uniformity measurements, heating measurements, and software verification/validation. A clinical study of 12 individuals was conducted to evaluate Peripheral Nerve Stimulation (PNS) effects. No diagnostic clinical trials were required; sample clinical images were provided to demonstrate performance.

Technological Characteristics

0.55T actively shielded superconducting magnet; 80 cm bore. Includes gradient coils, RF system, myExam 3D camera, and various coils (Body, Head/Neck, Spine, BioMatrix Contour). Connectivity via DICOM. Software syngo MR XA40A. Conforms to IEC 60601-1, IEC 60601-2-33, ISO 14971, IEC 62304, and NEMA MS standards.

Indications for Use

Indicated for patients requiring magnetic resonance imaging of the head, body, or extremities to assist in diagnosis. No specific age or gender contraindications provided.

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

MAGNETOM Sempra (K183221)

Reference Devices

MAGNETOM Aera with syngo MR XA30A (K202014)
MAGNETOM C! (K082331)

Related Devices

K220575 — MAGNETOM Free.Max, MAGNETOM Free.Star · Siemens Medical Solutions USA, Inc. · Jun 24, 2022
K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise · Siemens Healthcare GmbH · Dec 19, 2025
K251822 — MAGNETOM Free.Max; MAGNETOM Free.Star · Siemens Shenzhen Magnetic Resonance , Ltd. · Nov 20, 2025
K121160 — MAGNETOM SPECTRA · Siemens Medical Solutions USA, Inc. · Jul 16, 2012
K253779 — SIGNA Sprint Select · Ge Medical Systems, LLC · Feb 5, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". Siemens Medical Solutions USA, Inc. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A Malvern, Pennsylvania 19355 Re: K210611 Trade/Device Name: MAGNETOM Free.Max Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: May 27, 2021 Received: June 1, 2021 Dear Andrew Turner: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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. 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 803) for July 1, 2021 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210611 Device Name MAGNETOM Free.Max #### Indications for Use (Describe) The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Section 5: 510(k) Summary K210611 # Section 5 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92. ## 1. General Information | Establishment: | Siemens Medical Solutions USA, Inc. | |----------------|-------------------------------------| | | 40 Liberty Boulevard | | | Mail Code 65-1A | | | Malvern, PA 19355, USA | | | Registration Number: 2240869 | #### June 30, 2021 Date Prepared: Siemens Shenzhen Magnetic Resonance Ltd. Manufacturer: Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen PEOPLE'S REPUBLIC OF CHINA Registration Number: 3004754211 > Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157 #### 2. Contact Information Andrew Turner, Requlatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: (610) 850-5627 Fax: (610) 448-1787 E-mail: andrew.turner@siemens-healthineers.com Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A {4}------------------------------------------------ #### Device Name and Classification 3. | Device name: | MAGNETOM Free.Max | |-----------------------|---------------------------------------------| | Trade name: | MAGNETOM Free.Max | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH Secondary: MOS | ## 4. Legally Marketed Predicate Device | Trade name: | MAGNETOM Sempra | |-----------------------|---------------------------------------------| | 510(k) Number: | K183221 | | Clearance Date: | February 14, 2019 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | ## 5. Intended Use The indications for use for the subject devices are within that of the predicate device: The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis. #### 6. Device Description The subject device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a triangular shape. MAGNETOM Free.Max is a MRI system that has equivalencies to the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221, cleared on February 14, 2019). Whilst the subject device comes with significant new and modified hardware, the resultant customer clinical value is based on the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221). A high level summary of the new hardware comparing to the predicate device is provided below: | Hardware New Hardware | - | Magnet with no Quench Pipe including Autoramp up and Ramp down capability | |-----------------------|---|---------------------------------------------------------------------------------------| | | - | Gradient Coil and Gradient Power Amplifier | | | - | System Cover | | | - | Patient Table (fixed with/without vertical drive) | | | - | RF system | | | - | Select&GO Display (TPAN_2G) and Control Panel (CPAN_2G) | | | - | Patient Communication Unit (Intercom with System Power On/Off Function integrated) | | | - | Computer system | | | - | myExam 3D Camera | | New Coils | - | Body Coil | | | - | Head/Neck Coil | | | - | Spine Coil | | | - | BioMatrix Contour L Coil | | | - | Contour S Coil | lole software syngo MR XA40A brings new/modified software features: | Software | New Applications/ Software Features | |----------|-------------------------------------------| | | - Sequence Booster | | | - SMS Averaging | | | - SWI with 3D segmented EPI | | | - Ramp sampling mode | | | - Skewed SPAIR | | | - Accelerated Shim (STEAM-based field map | | | - Deep Resolve Gain | | | - Deep Resolve Sharp | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. The following new features for the subject device are migrated from the reference software version syngo MR XA30A (K202014, September 8, 2020): - ı Motion correction for Haste with multiple averages - myExam Companion, which consists of: New Software Platform/ Workflow - myExam 3D camera ー - myExam Cockpit (new name for Dot — Cockpit) - myExam Assist (new name for Dot | Engines) - myExam Autopilot. - New Scanner User Interface: । - Manual positioning — - Select&GO extension - Guidance of general patient setup, and coil preparation - । System functional safety test Modified Software Software Platform/ Workflow ı Improved System on/off/standby behavior # 7. Substantial Equivalence MAGNETOM Free.Max with software syngo MR XA40A is substantially equivalent to the predicate device: | Predicate Device | FDA Clearance Number and Date | Product Code | Manufacturer | |---------------------------------------|---------------------------------------|-----------------|----------------------------| | MAGNETOM Sempra with syngo MR XA12 | K183221, cleared February 14, 2019 | LNH LNI, MOS | Siemens Healthcare GmbH | The subject software syngo MR XA40A is modified based on the reference software XA30A; MAGNETOM C!, which is a low field device(0.35T) with permanent magnet is listed as a reference device as well: | Reference Devices | FDA Clearance Number and Date | Product Code | Manufacturer | |--------------------------------------|---------------------------------------|------------------|------------------------------------------------| | MAGNETOM Aera with syngo MR XA30A | K202014, cleared September 8, 2020 | LNH, LNI, MOS | Siemens AG / Siemens Healthcare GmbH | | MAGNETOM C! | K082331, cleared October 1, 2008 | LNH, MOS | Siemens Shenzhen Magnetic Resonance Ltd. | {7}------------------------------------------------ #### Technological Characteristics 8. The subject device. MAGNETOM Free.Max with software syngo MR XA40A. is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance. The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards. There are some differences in technological characteristics between the subject device and predicate device, including different hardware and modified software. These differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device. # 9. Nonclinical Tests | Performance Test | Tested Hardware or Software | Source/Rationale for test | |----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Sample clinical images | Coils, new and modified software features, pulse sequence types | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices | | Image quality assessments by sample clinical images. In some cases, a comparison of the image quality / quantitative data was made. | - new / modified pulse sequence types and algorithms. - comparison images between the new / modified features and the predicate device features | Diagnostic Devices | | Performance bench test | - SNR and image uniformity measurements for coils - heating measurements for coils | | | Software verification and validation | mainly new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | The following performance testing was conducted on the subject devices. The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared. ## 10. Clinical Tests / Publications In order to practically learn Peripheral Nerve Stimulation (PNS) effects of the subject system, a clinical study of 12 individuals were conducted (see Results of stimulation study in Appendix 3). {8}------------------------------------------------ No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. Clinical publications were referenced to provide information on the use of the following features and functions. | Feature / Function | Clinical Publication | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SMS Averaging for TSE | [1] C. H. OH et al., 1984. Line-Integral Projection Reconstruction (LPR) with Slice Encoding Techniques: Multislice Regional Imaging in NMR Tomography, IEEE Trans Med Imaging. 1984; 3(4):170-178 | | Ramp sampling mode for Beat | [2] Matt A.Bernstein, Kevin F.king, Xiaohong Joe Zhou, Handbook Of MRI Pulse Sequences, 2004: P706-P712. | | SWI with 3D segmented EPI | [3] Zwanenburg JJ, et al. Fast high resolution whole brain T2* weighted imaging using echo planar imaging at 7T. Neuroimage. 2011; 56:1902-1907. | | Accelerated Shim (STEAM-based field map) | [4] Liu W, et al. 3D Flow Compensated Interleaved EPI for a Fast High-Resolution Susceptibility-Weighted Imaging at 1.5T. Proc. Intl. Soc. Mag. Reason. Med 2019; 27: 3326. | | | [5] Nehrke, K., and Börnert, P. "DREAM—a novel approach for robust, ultrafast, multislice B1 mapping." Magnetic resonance in medicine 68.5 (2012): 1517-1526. | | Skewed SPAIR | [6] Hwang, T. L., van Zijl, P. C., and Garwood, M. 1999. Asymmetric adiabatic pulses for NH selection. J. Magn. Reson. 138: 173-177. | | | [7] Pfeuffer J. et al. "Zoomed Functional Imaging in the Human Brain at 7 Tesla with Simultaneous High Spatial and High Temporal Resolution” Neurolmage 17(1), 2002, p. 272- 286. | | Deep Resolve Gain | [8] Kellman P. et al. Image Reconstruction in SNR Units: A General Method for SNR Measurement. MRM 2005; 54:1439. Erratum in MRM 2007; 58:311. | | | [9] Blu T. et al. The SURE-LET approach to image denoising IEEE Transactions on Image Processing 16(11):2778-86 | | Deep Resolve Sharp | [10] Yulun Zhang, et al. Residual Dense Network for Image Super-Resolution, IEEE conference on computer vision and pattern recognition. 2018 | | | [11] Eirikur Agustsson, Radu Timofte. NTIRE 2017 Challenge on Single Image Super-Resolution: Dataset and Study. CVPRW, 2017. 5 | | | [12] Justin Johnson, et al. Perceptual Losses for Real-Time Style Transfer and Super-Resolution. European conference on computer vision. Springer, Cham, 2016 | Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A {9}------------------------------------------------ ## 11. Safety and Effectiveness The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device. Risk Management is ensured via a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images. MAGNETOM Free.Max with software syngo MR XA40A conform to the following FDA recognized and international IEC, ISO and NEMA standards: | Recognition Number | Product Area | Title of Standard | Reference Number and date | Standards Development Organization | |-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------| | 19-4 | General | Medical electrical equipment - part 1: general requirements for basic safety and essential performance | ES60601- 1:2005/(R) 2012 and A1:2012 | AAMI / ANSI | | 19-8 | General | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 60601-1-2, Ed. 4.0:2014 | IEC | | 12-295 | Radiology | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | 60601-2-33, Ed. 3.2 b:2015 | IEC | | 5-40 | General | Medical devices - Application of risk management to medical devices | 14971, Ed. 2:2007 | ISO | | 5-114 | General | Medical devices - Application of usability engineering to medical devices | 62366, Edition 1.0:2015 | AAMI ANSI IEC | | 13-79 | Software | Medical device software - Software life cycle processes | 62304:2006 + A1:2015 | AAMI ANSI IEC | | 12-232 | Radiology | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices | MS 4:2010 | NEMA | ### Traditional Premarket Notification 510(k) {10}------------------------------------------------ ## Section 5: 510(k) Summary | 12-288 | Radiology | Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI) | MS 9:2008 | NEMA | |--------|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------| | 12-300 | Radiology | Digital Imaging and Communications in Medicine (DICOM) Set 03/16/2012 Radiology | PS 3.1 - 3.20:2016 | NEMA | | 2-258 | Biocompatibility | biological evaluation of medical devices - part 1: evaluation and testing within a risk management process (Biocompatibility) | 10993-1:2018 | AAMI ANSI ISO | # 12. Conclusion as to Substantial Equivalence MAGNETOM Free.Max with software syngo MR XA40A has the same basic technological characteristics as the predicate device, MAGNETOM Sempra with syngo MR XA12, with respect to the magnetic resonance features and functionalities. And the indications for use of the subject device falls within the intended use of the predicate device. While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference devices. Siemens believes that MAGNETOM Free.Max with software syngo MR XA40A is substantially equivalent to the currently marketed device MAGNETOM Sempra with software syngo MR XA12 (K183221, cleared on February 14, 2019).