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.

Device Description

The subject devices MAGNETOM Free.Max and MAGNETOM Free.Star with software version syngo MR XA80A, consists of new and modified hardware and software features comparing to the predicate device MAGNETOM Free.Max and MAGNETOM Free.Star with software version syngo MR XA60A (K231617).

New hardware features (Only for MAGNETOM Free.Max):

Dental coil
High-end host
syngo Workplace

Modified hardware features:

MaRS
Select&GO Display (TPAN_3G)

New Pulse Sequences/ Software Features / Applications:

Only for MAGNETOM Free.Max:

EP_SEG_FID_PHS
EP2D_FID_PHS
EP_SEG_PHS
GRE_Proj
GRE_PHS
myExam Dental Assist
Select&GO Dental
Slice Overlapping

For both MAGNETOM Free.Max and MAGNETOM Free.Star:

Eco Power Mode
Extended Gradient Eco Mode
System Startup Timer

Modified Features and Applications:

myExam RT Assist (only for MAGNETOM Free.Max)
Deep Resolve for HASTE
Deep Resolve for EPI Diffusion
Select&GO for dental (only for MAGNETOM Free.Max)
Select&GO extension: Patient Registration and Start Scan
SPACE improvement: MTC prep module

Other Modifications and Minor Changes:

MAGNETOM Free.Max Dental Edition marketing bundle (only for MAGNETOM Free.Max)
MAGNETOM Free.Max RT Pro Edition marketing bundle (only for MAGNETOM Free.Max)
Off-Center Planning Support
ID Gain

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for MAGNETOM Free.Max and MAGNETOM Free.Star (K251822) offer high-level information regarding the devices and their comparison to predicate devices. However, it does not explicitly detail acceptance criteria (performance metrics with pass/fail thresholds) or a specific study proving the device meets those criteria for the overall device clearance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for general MR diagnostic imaging. The most detailed performance evaluation mentioned is for the AI feature "Deep Resolve Boost." Therefore, the response will focus on the information provided regarding Deep Resolve Boost, and address other points based on what is stated and what is not.

Acceptance Criteria and Device Performance (Focusing on Deep Resolve Boost)

Table 1. Deep Resolve Boost Performance Summary

Metric	Acceptance Criteria (Implicit from "significantly better")	Reported Device Performance
Structural Similarity Index (SSIM)	Significantly better structural similarity with the gold standard than conventional reconstruction.	Deep Resolve reconstruction has significantly better structural similarity with the gold standard than the conventional reconstruction.
Peak Signal-to-Noise Ratio (PSNR) / Signal-to-Noise Ratio (SNR)	Significantly better SNR than conventional reconstruction.	Deep Resolve reconstruction has significantly better signal-to-noise ratio (SNR) than the conventional reconstruction, and visual evaluation confirmed higher SNR.
Aliasing Artifacts	Not found to have caused artifacts.	Deep Resolve reconstruction was not found to have caused artifacts.
Image Sharpness	Superior sharpness compared to conventional reconstruction.	Visual evaluation confirmed superior sharpness.
Denoising Levels	Improved denoising levels.	Visual evaluation confirmed improved denoising Levels (implicit in higher SNR and image quality).

Note: The document does not provide numerical thresholds or specific statistical methods used to define "significantly better" for SSIM and PSNR. The acceptance criteria are implicitly derived from the reported positive performance relative to conventional reconstruction.

Study Details for Deep Resolve Boost

Sample Size used for the test set and the data provenance:
- Test Data: A "set of test data" was used for quantitative metrics (SSIM, PSNR) and visual evaluation. This test data was a "retrospectively undersampled copy of the test data" which was also used for conventional reconstruction.
- Provenance: "In-house measurements and collaboration partners."
- Retrospective/Prospective: The process of creating the test data by manipulating (undersampling) retrospectively acquired data indicates a retrospective approach.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. The document states, "Visual evaluation was performed by qualified readers."
- Qualifications of Experts: "Qualified readers." No further specific qualifications (e.g., years of experience, specialty) are provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document states, "Visual evaluation was performed by qualified readers." It does not mention whether multiple readers were used per case or how discrepancies were resolved.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not explicitly described for the Deep Resolve Boost feature. The visual evaluation was focused on comparing images reconstructed with conventional methods versus Deep Resolve Boost, primarily to assess image quality attributes without explicit human performance metrics (e.g., diagnostic accuracy, reading time).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The quantitative metrics (SSIM, PSNR) and the visual assessment of images reconstructed solely by the algorithm (Deep Resolve Boost) were performed to characterize the network's impact independently.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "acquired datasets represent the ground truth for the training and validation." Input data for testing was "retrospectively created from the ground truth by data manipulation and augmentation." This implies that the raw, fully sampled, and high-quality MRI acquisitions are considered the ground truth against which the reconstructed images (conventional and Deep Resolve Boost) are compared. This is a technical ground truth rather than a clinical ground truth like pathology.
The sample size for the training set:
- TSE: More than 25,000 slices.
- HASTE: Pretrained on the TSE dataset and refined with more than 10,000 HASTE slices.
- EPI Diffusion: More than 1,000,000 slices.
How the ground truth for the training set was established:
- "The acquired datasets represent the ground truth for the training and validation."
- Input data for training was "retrospectively created from the ground truth by data manipulation and augmentation." This included "further under-sampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data."
- This indicates that the ground truth for training was derived from high-quality, fully sampled MRI acquisitions, which were then manipulated to simulate lower quality inputs for the AI to learn from.

Summary

FDA 510(k) Clearance Letter - MAGNETOM Free.Max and Free.Star

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

November 20, 2025

Siemens Shenzhen Magnetic Resonance Ltd.
℅ Alina Goodman
Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, Pennsylvania 19355

Re: K251822
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

Dear Alina Goodman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 20, 2025. Specifically, FDA is updating this substantial equivalence (SE) letter as an administrative correction to include the IFU for K251822, as it was inadvertently excluded from our SE letter dated November 20, 2025.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Daniel Krainak, OHT8: Office of Radiological Health, 301-796-0478, Daniel.Krainak@fda.hhs.gov.

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

Page 2

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

November 20, 2025

Siemens Shenzhen Magnetic Resonance Ltd.
℅ Alina Goodman
Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, Pennsylvania 19355

Re: K251822
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: October 20, 2025
Received: October 20, 2025

Dear Alina Goodman:

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.

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K251822 - Alina Goodman 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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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K251822 - Alina Goodman Page 3

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,

Enclosure

Page 5

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251822

Device Name:
MAGNETOM Free.Max
MAGNETOM Free.Star

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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."

Page 6

510(k) Summary

K251822

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: June 12, 2025

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

Alina Goodman
Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
Phone: +1(224)526-1404
E-mail: alina.goodman@siemenshealthineers.com

3. Device Name and Classification

Device/ Trade name: MAGNETOM Free.Max
MAGNETOM Free.Star

Classification Name: Magnetic Resonance Diagnostic Device (MRDD)

Classification Panel: Radiology

CFR Code: 21 CFR § 892.1000

Page 7

Classification: II

Product Code: Primary: LNH
Secondary: MOS

4. Legally Marketed Predicate Device and Reference Device

4.1 Predicate Device

Trade name: MAGNETOM Free.Max
510(k) Number: K231617
Classification Name: Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel: Radiology
CFR Code: 21 CFR § 892.1000
Classification: II
Product Code: Primary: LNH
Secondary: MOS

Trade name: MAGNETOM Free.Star
510(k) Number: K231617
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 Device

Trade name: MAGNETOM Sola
510(k) Number: K232535
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

Trade name: syngo.via VB40A¹
510(k) Number: K191040
Classification Name: Picture Archiving and Communications System
Classification Panel: Radiology
CFR Code: 21 CFR §892.2050
Classification: II
Product Code: LLZ

¹ The initial version VB40 was cleared on May 16, 2019 with K191040.
syngo.via VB80 is released via Non-Filing Justification.

Page 8

5. Intended Use/ Indications for Use

MAGNETOM Free.Max:

The indications for use statement for the subject device MAGNETOM Free.Max with syngo MR XA80A has been updated compared to the predicate device MAGNETOM Free.Max with syngo MR XA60A, to include "dentist trained in MRI" as a new intended user group in the statement:

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.

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 indications for use for the subject device MAGNETOM Free.Star with syngo MR XA80A is the same as the predicate device MAGNETOM Free.Star with syngo MR XA60A:

Indications for use modification rationale for MAGNETOM Free.Max:

The newly added intended user group in the subject device's indications for use statement does not affect the functionality of the device to produce images that may assist in diagnosis as a magnetic resonance diagnostic device. The submitted nonclinical data and clinical data demonstrate that the subject device is as safe and effective as the predicate device. Therefore, the difference does not constitute a new intended use according to FDA Guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]". The subject device has the same intended use as the predicate device.

Page 9

6. Device Description

Below is a high-level summary of the new and modified hardware and software features compared to the predicate devices MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA60A:

Hardware

New hardware features:

Dental coil (only for MAGNETOM Free.Max)
High-end host
syngo Workplace

Modified hardware features:

MaRS
Select&GO Display (TPAN_3G)

Software

New Pulse Sequences/ Software Features / Applications:

Only for MAGNETOM Free.Max:

EP_SEG_FID_PHS
EP2D_FID_PHS
EP_SEG_PHS
GRE_Proj
GRE_PHS
myExam Dental Assist
Select&GO Dental
Slice Overlapping

For both MAGNETOM Free.Max and MAGNETOM Free.Star:

Eco Power Mode
Extended Gradient Eco Mode
System Startup Timer

Modified Features and Applications:

myExam RT Assist (only for MAGNETOM Free.Max)
Deep Resolve for HASTE

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Deep Resolve for EPI Diffusion
Select&GO for dental (only for MAGNETOM Free.Max)
Select&GO extension: Patient Registration and Start Scan
SPACE improvement: MTC prep module

Other Modifications and Minor Changes:

MAGNETOM Free.Max Dental Edition marketing bundle (only for MAGNETOM Free.Max)
MAGNETOM Free.Max RT Pro Edition marketing bundle (only for MAGNETOM Free.Max)
Off-Center Planning Support
ID Gain

Below Table 1 shows an executive summary of training and validation dataset of AI feature Deep Resolve Boost in subject devices:

Table 1. Training and validation dataset of Deep Resolve Boost

Deep Resolve Boost
Training and Validation data	• TSE: more than 25,000 slices• HASTE: pretrained on the TSE dataset and refined with more than 10,000 HASTE slices• EPI Diffusion: more than 1,000,000 slicesThe data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength.
Sample source	In-house measurements and collaboration partners.
Equipment	0.55T[1], 1.5T and 3T MRI scanners
Protocols	Representative protocols (T1, T2 and PD with and without fat saturation) which have been altered (e.g. to increase SNR, increase resolution or reduced acceleration).
Clinical subgroups	No clinical subgroups have been defined for the datasets.
Demographic distribution	Due to reasons of data privacy, we did not record gender, age and ethnicity during data collection.
Confounders	No confounders have been defined for the datasets.
Test Statistics and Test Results Summary	The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM). Most importantly, the performance was evaluated by visual comparisons to evaluate for example, aliasing artifacts, image sharpness and denoising levels.The quality metrics evaluation was performed by conventional reconstruction of a set of test data (gold standard). This test data

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set was compared against a retrospectively undersampled copy of the test data, which was reconstructed with both conventional and Deep Resolve Boost reconstruction. The SSIM metric shows that the Deep Resolve reconstruction has significantly better structural similarity with the gold standard than the conventional reconstruction. Likewise, the PSNR metric shows that the Deep Resolve reconstruction has significantly better signal-to-noise ratio (SNR) than the conventional reconstruction.

Visual evaluation was performed by qualified readers. Pairs of images where the same dataset (or two consecutive scans) was reconstructed both with conventional and Deep Resolve Boost reconstruction were examined for image quality with a focus on aliasing artifacts, image sharpness and SNR. In conclusion, all images show that the Deep Resolve Boost reconstruction results in higher SNR, and superior sharpness. Deep Resolve reconstruction was not found to have caused artifacts.

Reference standard	The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further under-sampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data.
Data independency	The dataset was randomly split into two independent training and validation datasets. Data split maintained similar data distribution in both training and validation datasets.

[1] To confirm the applicability of the networks to 0.55T, additional validation of 0.55T datasets covering a broad range of body regions was performed both by calculating metrics and performing visual image comparisons.

7. Substantial Equivalence

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA80A are substantially equivalent to the predicate devices and include migrated features from the following references devices (see Table 2):

Table 2. Predicate devices and reference devices

Predicate Device	FDA Clearance Number and Date	Product Code	Manufacturer
MAGNETOM Free.Max with syngo MR XA60A	K231617, cleared on November 09, 2023	LNH, MOS	Siemens Shenzhen Magnetic Resonance Ltd.
MAGNETOM Free.Star with syngo MR XA60A	K231617, cleared on November 09, 2023	LNH, MOS	Siemens Shenzhen Magnetic Resonance Ltd.

Reference Device	FDA Clearance Number and Date	Product Code	Manufacturer
MAGNETOM Sola with syngo MR XA61A	K232535, cleared on December 22, 2023	LNH, LNI, MOS	Siemens Healthcare GmbH
syngo.via VB40A¹	K191040, cleared on May 16, 2019	LLZ	Siemens Healthcare GmbH

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8. Technological Characteristics

The subject devices, MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA80A, 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 nonclinical and clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate devices.

Please see below Table 3 and Table 4 for the comparison between subject devices and predicate/ reference devices.

Table 3. Hardware Comparison

Hardware	Subject Devices	Predicate Devices
	MAGNETOM Free.Max with syngo MR XA80A	MAGNETOM Free.Star with syngo MR XA80A
Magnet System	Yes, same as predicate device	Yes
RF System	Yes, same as predicate device	Yes
Transmission technique – RF Body Coil	Yes, same as predicate device	Yes
Gradient System	Yes, same as predicate device	Yes
Patient Table	Yes, same as predicate device	Yes
Computer	Yes, modified compared to predicate devices:-new high-end host computer hardware-new syngo Workplace-modified MaRS hardware	Yes
Coils	Yes, new coil compared to predicate device:-Dental coil	Yes, same as predicate device
Other HW components	Yes, modified compared to predicate device:-Select&GO display (TPAN 3G)	Yes

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Table 4. Software Features Comparison

Software	Subject Devices	Predicate Device
	MAGNETOM Free.Max with software syngo MR XA80A	MAGNETOM Free.Star with software syngo MR XA80A

Sequences

SE-based pulse sequence types	Yes, with new and modified features compared to predicate devices:-Slice Overlapping for TSE and TSE_DIXON- Deep Resolve for HASTE- SPACE improvement with MTC prep module	Yes
GRE-based/Steady-State Pulse Sequence Types	Yes, with new pulse sequences compared to predicate devices:-GRE_PHS-GRE_Proj	Yes
EPI-based Pulse Sequence Types	Yes, with new pulse sequences and modified features compared to predicate devices:-Deep Resolve for EP2D_DIFF-EP_SEG_PHS-EP_SEG_FID_PHS-EP2D_FID_PHS	Yes

Feature and Applications

Application Suites	Yes, with new feature: Dental Suite	Yes, same as predicate device	Yes
myExam AutoPilot	Yes, same as predicate device	Yes
myExam Assist	Yes, with new and modified features:-myExam Dental Assist-myExam RT Assist	Yes, same as predicate device	Yes
Inline Postprocessing Functions	Yes, same as predicate device	Yes
Visualization	Yes, same as predicate device	Yes
Basic Post-Processing	Yes, same as predicate device	Yes
Communication	Yes, same as predicate device	Yes
Application and post-processing	Yes, same as predicate device	Yes
Other Software Feature / Application	Yes, same as predicate device	Yes
Software Platform and General Workflow	Yes, with new and modified features:-Select&GO workflow extension-Eco Power Mode-Extended Gradient Eco Mode-System Startup Timer	Yes

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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	new coil, new features and modified features in the pulse sequence types	Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Image quality statement by U.S. board radiologist.	new coil	Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
SNR and Image Uniformity	new coil	Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Surface Heating	new coil	Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Software verification and validation	Mainly new and modified software features	Guidance for the Content of Premarket Submissions for Software Contained in Medical 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

A clinical investigation report was submitted to provide data acquired from a clinical setting for the subject device MAGNETOM Free.Max. The primary objective of this clinical investigation was to evaluate the diagnostic image quality of MAGNETOM Free.Max in the dentomaxillofacial region of healthy volunteers and patients. Data collected from the study demonstrated the diagnostic image quality of the MR images of the dentomaxillofacial region was adequate in a clinical setting, as well as the safety of using MAGNETOM Free.Max.

Sample clinical images were provided to support substantial equivalence for the subject devices.

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

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recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the devices are intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA80A 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	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
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
12-352	Radiology	Digital Imaging and Communications in Medicine (DICOM) Set	PS 3.1 - 3.20 (2023e)	NEMA
2-258	Biocompatibility	biological evaluation of medical devices - part 1: evaluation and testing within a risk management process (Biocompatibility)	10993-1:2018	ISO

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12. Conclusion as to Substantial Equivalence

MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA80A have the same basic technological characteristics as the predicate device systems, MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA60A (Cleared with K231617 on November 9, 2023), 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 devices and reference devices.

Siemens believes that MAGNETOM Free.Max and MAGNETOM Free.Star with software syngo MR XA80A are substantially equivalent to the currently marketed device MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA60A.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.