MAGNETOM Free.Max; MAGNETOM Free.Star
Device Facts
| Record ID | K260758 |
|---|---|
| Device Name | MAGNETOM Free.Max; MAGNETOM Free.Star |
| Applicant | Siemens Shenzhen Magnetic Resonance , Ltd. |
| Product Code | LNH · Radiology |
| Decision Date | Sep 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, 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 or dentist trained in MRI yield information that may assist in diagnosis. The MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as MR Safe biopsy needles. When operated by dentists and dental assistants trained in MRI, the MAGNETOM MR system must only be used for scanning the dentomaxillofacial region.
Device Story
MAGNETOM Free.Max and Free.Star are magnetic resonance diagnostic devices (MRDD) producing cross-sectional images of internal structures/functions. Systems utilize optional local coils and contrast agents; operated by trained physicians or dentists in clinical settings. Inputs include RF signals and magnetic field gradients; processed via Syngo MR XB10 software to generate diagnostic images and derived physical parameters. New features include Contour M Coil, Multi-Index MR PT Positioning, and various software applications (e.g., MRE, PC, breast biopsy, Deep Resolve Boost/Sharp). System supports interventional procedures using MR-safe biopsy needles. Output images assist in clinical diagnosis. Benefits include high-quality diagnostic imaging across diverse patient populations, including neonates. System integrates with third-party tools (QED Surewave, Resoundant) and includes workflow enhancements like Open Workflow and Open Recon 2.0.
Clinical Evidence
No clinical trials were conducted. Evidence consists of bench testing, software verification and validation, and sample clinical images. Compliance with electrical, mechanical, and safety standards (IEC 60601-1, IEC 60601-2-33) was demonstrated. Clinical publications were referenced to support the utility of specific features.
Technological Characteristics
Magnetic resonance diagnostic device; utilizes phased array coils; software-controlled image acquisition and reconstruction. Standards: IEC 60601-1 (safety), IEC 60601-2-33 (MR safety), ISO 14971 (risk management), IEC 62304 (software lifecycle), DICOM (connectivity). Features include Deep Resolve (AI-based reconstruction), Open Recon 2.0, and various MRE/PC applications. System is networked for DICOM communication.
Indications for Use
Indicated for patients of all ages (neonates to adults) requiring MRI diagnostic imaging of the head, body, or extremities; includes interventional procedures with MR-compatible devices; dentomaxillofacial imaging for dental professionals.
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
Reference Devices
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
September 1, 2026
Siemens Shenzhen Magnetic Resonance, Ltd.
% Martin Rajchel
Sr. Manager, Regulatory Affairs
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern, Pennsylvania 19355
Re: K260758
Trade/Device Name: MAGNETOM Free.Max;
MAGNETOM Free.Star
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH, MOS
Dated: July 22, 2026
Received: July 22, 2026
Dear Martin Rajchel:
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 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
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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-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.
K260758
Please provide the device trade name(s).
MAGNETOM Free.Max;
MAGNETOM Free.Star
Please provide your Indications for Use below.
MAGNETOM Free.Max:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, 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 or dentist trained in MRI yield information that may assist in diagnosis.
The MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as MR Safe biopsy needles.
When operated by dentists and dental assistants trained in MRI, the MAGNETOM MR system must only be used for scanning the dentomaxillofacial region.
MAGNETOM Free.Star:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, 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.
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)
Please select the age group(s) for which the device(s) is to be used.
☑ Neonates/Newborns (Birth to < 29 days old)
☑ Infants (29 days old to < 2 years old)
☑ Children (2 years old to < 12 years old)
☑ Adolescents (12 years old to < 22 years old)
☑ Adults (22 years old and greater)
?
?
?
?
?
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SIEMENS
Healthineers
510(k) Summary
# 510(k) Summary
K260758
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
Malvern, PA 19355, USA
Registration Number: 2240869
Date Prepared: March 2, 2026
Manufacturer: Siemens Shenzhen Magnetic Resonance Ltd.
Siemens MRI Center, Gaoxin C. Ave., 2nd
Hi-Tech Industrial Park
518057 Shenzhen
PEOPLE'S REPUBLIC OF CHINA
Registration Number: 3004754211
Siemens Healthineers AG
Magnetic Resonance (MR)
Allee am Röthelheimpark 2
91052 Erlangen
Germany
Registration Number: 3002808157
2. Contact Information
Martin Rajchel
Sr. Manager, Regulatory Affairs
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
Phone: +1 4844734209
E-mail: martin.rajchel@siemens-healthineers.com
3. Device Name and Classification
Device/ Trade name: MAGNETOM Free.Max
MAGNETOM Free.Star
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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SIEMENS
Healthineers
510(k) Summary
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 Devices and Reference Devices
#### 4.1 Predicate Devices
Trade name: MAGNETOM Free.Max
MAGNETOM Free.Star
510(k) Number: K251822
Clearance Date: November 20, 2025
Classification Name: Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel: Radiology
CFR Code: 21 CFR § 892.1000
Classification: II
Product Code: Primary: LNH
Secondary: MOS
#### 4.2 Reference Devices
Trade name: MAGNETOM Sola
MAGNETOM Vida
MAGNETOM Flow.Neo
510(k) Number: K252838
Clearance Date: December 19, 2025
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 / Indications for Use
The indications for use for the subject devices are the same as for the predicate devices:
#### MAGNETOM Free.Max:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, 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
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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SIEMENS Healthineers
510(k) Summary
and the physical parameters derived from the images when interpreted by a trained physician or dentist trained in MRI yield information that may assist in diagnosis.
The MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles.
When operated by dentists and dental assistants trained in MRI, the MAGNETOM MR system must only be used for scanning the dentomaxillofacial region.
# MAGNETOM Free.Star:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, 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
MAGNETOM Free.Max & MAGNETOM Free.Star with software Syngo MR XB10 include new and modified hardware and software compared to the predicate devices, MAGNETOM Free.Max & MAGNETOM Free.Star with software syngo MR XA80A. A high-level summary of the new and modified hardware and software is provided below:
| Type | Modification (compared to predicate devices) | Features |
| --- | --- | --- |
| Hardware | **Modified**, Body region extension | - Contour M Coil |
| Other Modifications and / or Minor Changes | **New** | - Combination with 3^{rd} party QED Surewave - Combination with 3^{rd} party Resoundant - MR Workplace – Tool for Monitor Calibration **Only for MAGNETOM Free.Max:** - Combination with 3^{rd} party Breast Biopsy Set for Breast BI Coil |
| | **Modified**, same as predicate, | - Functional Lung Imaging |
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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SIEMENS Healthineers
510(k) Summary
| | but with new claim introduced | |
| --- | --- | --- |
In addition, the following hardware and software are transferred from the reference devices MAGNETOM Sola, MAGNETOM Vida & MAGNETOM Flow.Neo with software Syngo MR XB10 (K252838), to the subject devices without any modifications:
| Type | Modification (compared to predicate devices) | Features (transferred without any modifications) |
| --- | --- | --- |
| **Hardware** | **New** | **Only for MAGNETOM Free.Max:** - Multi-Index MR PT Positioning |
| **Software** | **New** Features and Applications | - EP2D_SE_MRE - GRE_MRE - GRE_PC **Only for MAGNETOM Free.Max:** - CS_VIBE - myExam Breast Assist - MR Breast Biopsy |
| | **Modified** Features and Applications | - Deep Resolve Boost for FL3D_VIBE and SPACE - Deep Resolve Boost for TSE - Deep Resolve Sharp for FL3D_VIBE and SPACE |
| | **New** Software / Platform | - Open Workflow |
| | **Modified** Software / Platform | - Open Recon 2.0 |
| **Other Modifications and / or Minor Changes** | **New** | - Eco Power Mode Pro **Only for MAGNETOM Free.Max:** - Footswitch |
### 7. Substantial Equivalence
MAGNETOM Free.Max & MAGNETOM Free.Star with software Syngo MR XB10 are substantially equivalent to the following predicate devices:
| Predicate Devices | FDA Clearance Number and Date | Product Code | Manufacturer |
| --- | --- | --- | --- |
| MAGNETOM Free.Max with syngo MR XA80A | K251822, cleared on November 20, 2025 | LNH MOS | Siemens Shenzhen Magnetic Resonance Ltd. |
| MAGNETOM Free.Star with Syngo MR XA80A | K251822, cleared on November 20, 2025 | LNH MOS | Siemens Shenzhen Magnetic Resonance Ltd. |
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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SIEMENS Healthineers
510(k) Summary
MAGNETOM Free.Max & MAGNETOM Free.Star with software Syngo MR XB10 include hardware and software already cleared on the following reference devices:
| Reference Devices | FDA Clearance Number and Date | Product Code | Manufacturer |
| --- | --- | --- | --- |
| MAGNETOM Sola with Syngo MR XB10 | K252838, cleared on December 19, 2025 | LNH LNI, MOS | Siemens Healthineers AG |
| MAGNETOM Vida with Syngo MR XB10 | K252838, cleared on December 19, 2025 | LNH LNI, MOS | Siemens Healthineers AG |
| MAGNETOM Flow.Neo with Syngo MR XB10 | K252838, cleared on December 19, 2025 | LNH LNI, MOS | Siemens Healthineers AG |
## 8. Comparison of technological Characteristics with the Predicate Devices
The subject devices, MAGNETOM Free.Max & MAGNETOM Free.Star with software Syngo MR XB10 are substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system and performance.
The subject devices conform 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 devices and predicate devices, including new and modified hardware and software features. These differences have been tested and the conclusion from the non-clinical and clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate devices.
## 9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
| --- | --- | --- |
| Sample clinical images | Coils, new and modified software features | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices |
| Performance bench test | new and modified hardware | |
| Software verification and validation | new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| Electrical, mechanical, structural, and related system safety test | complete system | - AAMI / ANSI ES60601-1 - IEC 60601-2-33 |
| Electrical safety and electromagnetic compatibility (EMC) | complete system | IEC 60601-1-2 |
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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**SIEMENS**
**Healthineers**
510(k) Summary
The results from each set of tests demonstrate that the subject devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.
## 10. Clinical Tests / Publications
No additional clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided. Clinical publications were referenced to provide information on the use of some of the features and functions.
## 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 Shenzhen Magnetic Resonance Ltd. 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 & MAGNETOM Free.Star with software Syngo MR XB10 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 |
| --- | --- | --- | --- | --- |
| 19-46 | General II (ES/ EMC) | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) | ES60601-1:2005 /(R)2012 & A1:2012, C1:2009/(R)2012 &A2:2010/(R)2012 (Cons. Text) [Incl.AMD2:2021] | ANSI AAMI |
| 19-36 | 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 Edition 4.1 2020-09 | IEC |
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
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**SIEMENS**
**Healthineers**
510(k) Summary
| 12-347 | 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 Edition 4.0 2022-08 | IEC |
| --- | --- | --- | --- | --- |
| 5-125 | General I (QS/ RM) | Medical devices - Application of risk management to medical devices | 14971 Third edition 2019-12 | ISO |
| 5-129 | General I (QS/ RM) | Medical devices - Part 1: Application of usability engineering to medical devices | 62366-1: 2015 + AMD1:2020 | ANSI AAMI IEC |
| 13-79 | Software/ Informatics | Medical device software - Software life cycle processes [Including Amendment 1 (2016)] | IEC 62304:2006 + AMD1:2015 | IEC |
| 12-232 | Radiology | Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images | MS 9-2008 (R2020) | NEMA |
| 12-363 | Radiology | Digital Imaging and Communications in Medicine (DICOM) | PS 3.1. - 3.20 (2024e) | NEMA |
| 2-258 | Biocompatibility | Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. (Biocompatibility) | 10993-1: 2018 | ANSI AAMI ISO |
## 12. Conclusion as to Substantial Equivalence
MAGNETOM Free.Max & MAGNETOM Free.Star with software Syngo MR XB10 have the same intended use and same basic technological characteristics as the respective predicate device systems, MAGNETOM Free.Max & MAGNETOM Free.Star with software syngo MR XA80A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate devices, 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 & MAGNETOM Free.Star with software Syngo MR XB10 are substantially equivalent to the currently marketed MAGNETOM Free.Max & MAGNETOM Free.Star with software syngo MR XA80A (K251822, cleared on November 20, 2025).
Siemens MR Systems: MAGNETOM Free.Max, MAGNETOM Free.Star with Software Syngo MR XB10
