(26 days)
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, 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 and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 include new and modified hardware and software compared to the predicate devices, MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software syngo MR XA70A.
New compared to predicate:
- Spine support respiratory (Cushion) as a part of BM Spine Coil Set 1.5T (including new surface material)
- Gradient Configuration Upgrade
Modified same as predicate, but with new claim introduced:
- PETRA (new claim for the existing sequence)
In addition, the following hardware and software are transferred from the reference device MAGNETOM Flow.Neo with software Syngo MR XB10 (K252838), to the subject devices without any modifications:
Hardware (New compared to predicate, same as reference):
- BioMatrix Dockable Table with / without eDrive
- Comfort Sound: Cushion
Hardware (Modified compared to predicate, same as reference):
- Comfort Sound: BM Head/Neck Coil
- Relocatable Option
Software (New compared to predicate, same as reference):
- Open Workflow
Software (Modified compared to predicate, same as reference):
- BioMatrix Motion Sensor (SAMER)
- CS_VIBE
- SPAIR FatSat Improvements: SPAIR "Abdomen & Pelvis" mode and SPAIR Breast mode
- Deep Resolve Boost for FL3D_VIBE and SPACE
- Deep Resolve Sharp for FL3D_VIBE and SPACE
- Preview functionality for Deep Resolve Boost
- myExam Implant Suite
- GRE_PC
- Open Recon 2.0
- Deep Resolve Boost for TSE
- "MTC Mode" for SPACE
Other Modifications and / or Minor Changes (New compared to predicate, same as reference):
- Eco Power Mode Pro
Other Modifications and / or Minor Changes (Modified compared to predicate, same as reference):
- Off-Center Planning Support
- Flip Angle Optimization (Lock TR and FA)
- ID Gain (re-naming)
- Marketing bundle "myExam Companion"
Acceptance Criteria and Study Details for Siemens MAGNETOM Flow.Ace and Flow.Plus
Based on the provided 510(k) clearance letter, the acceptance criteria and study details are as follows. It's important to note that this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical trial for device efficacy. Therefore, specific metrics like sensitivity, specificity, or AUC for diagnostic performance are not explicitly stated as acceptance criteria in the typical sense for a new diagnostic claim.
The acceptance criteria are generally focused on demonstrating that the new and modified features of the MAGNETOM Flow.Ace and Flow.Plus systems maintain equivalent safety and performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Verification and Validation: New and modified software features conform to design specifications and perform as intended. | Testing demonstrated that the new and modified software features performed as intended, supporting substantial equivalence. |
| Functionality of New/Modified Hardware: New hardware ("Spine support respiratory (Cushion)"), and modified hardware ("BioMatrix Dockable Table with/without eDrive", "Comfort Sound: BM Head/Neck Coil", "Relocatable Option") perform as intended and safely. | Testing demonstrated that the new and modified hardware features performed as intended and safely, supporting substantial equivalence. |
| Biocompatibility: Surface of applied parts (Spine support respiratory cushion and Comfort Sound Cushion) in contact with patients is biocompatible. | Biocompatibility testing (per ISO 10993-1) was conducted, demonstrating compliance. |
| Electrical Safety and Electromagnetic Compatibility (EMC): The complete system complies with relevant safety and EMC standards. | Electrical safety and EMC testing (per IEC 60601-1 and related collateral standards) was conducted, demonstrating compliance. |
| Acoustic Noise: The device meets acoustic noise limits. | Acoustic noise measurement procedures (per NEMA MS 4-2010), were followed. |
| Compliance with General Standards: All modifications comply with recognized industry standards (e.g., IEC 60601-1 series, ISO 14971, IEC 62304, NEMA, DICOM). | The device conforms to the listed FDA recognized and international IEC, ISO, and NEMA standards. |
| Clinical Equivalence (through sample images and comparative literature): New features (e.g., Deep Resolve Boost, CS_VIBE, PETRA, BioMatrix Motion Sensor) provide information that assists in diagnosis, maintaining the existing indications for use. | Sample clinical images were provided as claim evidence. Clinical publications were referenced to support the use and performance of specific features (SAMER, CS_VIBE, PETRA). The conclusion was that the features bear an equivalent safety and performance profile. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a test set in the context of clinical images or patient data.
- Data Provenance: "Sample clinical images" were provided as "claim evidence." The origin (e.g., country) and whether this data was retrospective or prospective are not specified in the provided text. The clinical publications referenced are peer-reviewed articles, which would typically involve patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information regarding the number of experts, their qualifications, or how ground truth was established for any "test set" of images. The phrase "interpreted by a trained physician" is used in the Indications for Use, which is a general statement about MR diagnostic devices.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly done or reported in this document. The submission relies on "sample clinical images" as "claim evidence" and references existing clinical publications for certain features to demonstrate substantial equivalence, rather than a direct comparative study showing improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was Done
The document discusses "software verification and validation" and "nonclinical tests" which would imply standalone performance testing of the algorithms and features. However, it does not provide specific metrics or results for standalone algorithm performance (e.g., sensitivity, specificity, or AUC if applicable to specific features). The focus is on the performance of the integrated system.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any specific evaluation. The "Indications for Use" mention that images "when interpreted by a trained physician yield information that may assist in diagnosis." For the referenced clinical publications, the ground truth would depend on the methodology of those studies (e.g., pathology, clinical follow-up, expert consensus in a research setting), but this information is external to the 510(k) summary itself.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. This is a 510(k) submission for an updated MR system, not a de novo AI/ML device where training data details are typically prominent. While features like "Deep Resolve Boost" and "Deep Resolve Sharp" likely leverage AI/ML, the details of their development and training are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how ground truth was established for a training set.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
February 23, 2026
Siemens Shenzhen Magnetic Resonance, Ltd.
Martin Rajchel
Sr. Manager, Regulatory Affairs
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern, Pennsylvania 19355
Re: K260265
Trade/Device Name: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH, LNI, MOS
Dated: January 26, 2026
Received: January 28, 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.
Page 2
K260265 - Martin Rajchel
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K260265 - Martin Rajchel
Page 3
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-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
Page 4
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.
K260265
Please provide the device trade name(s).
MAGNETOM Flow.Ace;
MAGNETOM Flow.Plus
Please provide your Indications for Use below.
The indications for use for the subject devices:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, 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 and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
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)
Page 5
510(k) Summary
Siemens MR Systems: MAGNETOM Flow.Ace, MAGNETOM Flow.Plus with Software Syngo MR XB10
510(k) Summary
K260265
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: February, 16, 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
Page 6
3. Device Name and Classification
Device/ Trade name: MAGNETOM Flow.Ace
MAGNETOM Flow.Plus
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
4. Legally Marketed Predicate Devices and Reference Device
4.1 Predicate Devices
Trade name: MAGNETOM Flow.Ace
MAGNETOM Flow.Plus
510(k) Number: K250436
Clearance Date: June 16, 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
4.2 Reference Devices
Trade name: 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. Indications for Use
The indications for use for the subject devices are the same as for the predicate devices:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, 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 and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images
Page 7
and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 include new and modified hardware and software compared to the predicate devices, MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software syngo MR XA70A. A high-level summary of the new and modified hardware and software is provided below:
| Type | Modification Type for subject devices | Feature |
|---|---|---|
| Hardware | New compared to predicate | - Spine support respiratory (Cushion) as a part of BM Spine Coil Set 1.5T (including new surface material) |
| Software | New same as predicate, but with new Upgrade Option | - Gradient Configuration Upgrade |
| Other Modifications and / or Minor Changes | Modified same as predicate, but with new claim introduced | - PETRA (new claim for the existing sequence) |
In addition, the following hardware and software are transferred from the reference device MAGNETOM Flow.Neo with software Syngo MR XB10 (K252838), to the subject devices without any modifications:
| Type | Modification Type for subject devices | Feature |
|---|---|---|
| Hardware | New compared to predicate, same as reference (K252838) (transferred without modifications) | - BioMatrix Dockable Table with / without eDrive- Comfort Sound: Cushion |
| Modified compared to predicate, same as reference (K252838) (transferred without modifications) | - Comfort Sound: BM Head/Neck Coil- Relocatable Option |
Page 8
| Type | Modification Type for subject devices | Feature |
|---|---|---|
| Software | New compared to predicate, same as reference (K252838) (transferred without modifications) | - Open Workflow |
| Modified compared to predicate, same as reference (K252838) (transferred without modifications) | - BioMatrix Motion Sensor (SAMER)- CS_VIBE- SPAIR FatSat Improvements: SPAIR "Abdomen & Pelvis" mode and SPAIR Breast mode- Deep Resolve Boost for FL3D_VIBE and SPACE- Deep Resolve Sharp for FL3D_VIBE and SPACE- Preview functionality for Deep Resolve Boost- myExam Implant Suite- GRE_PC- Open Recon 2.0- Deep Resolve Boost for TSE- "MTC Mode" for SPACE | |
| Other Modifications and / or Minor Changes | New compared to predicate, same as reference (K252838) (transferred without modifications) | - Eco Power Mode Pro |
| Modified compared to predicate, same as reference (K252838) (transferred without modifications) | - Off-Center Planning Support- Flip Angle Optimization (Lock TR and FA)- ID Gain (re-naming)- Marketing bundle "myExam Companion" |
7. Substantial Equivalence
MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 are substantially equivalent to the following predicate devices:
| Predicate Devices | FDA Clearance Number and Date | Product Code | Manufacturer |
|---|---|---|---|
| MAGNETOM Flow.Ace with syngo MR XA70A | K250436, cleared on June 16, 2025 | LNH LNI, MOS | Siemens Shenzhen Magnetic Resonance Ltd. |
| MAGNETOM Flow.Plus with Syngo MR XA70A | K250436, cleared on June 16, 2025 | LNH LNI, MOS | Siemens Shenzhen Magnetic Resonance Ltd. |
MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 include hardware and software already cleared on the following reference device:
Page 9
| Reference Device | FDA Clearance Number and Date | Product Code | Manufacturer |
|---|---|---|---|
| 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 Flow.Ace & MAGNETOM Flow.Plus 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. Please see below Table 1 and Table 2 for the comparison between subject devices and predicate/ reference devices.
Table 1: Hardware Comparison
| Hardware | Subject Devices | Predicate Devices | Reference Device | ||
|---|---|---|---|---|---|
| MAGNETOM Flow.Ace with Syngo MR XB10 | MAGNETOM Flow.Plus with Syngo MR XB10 | MAGNETOM Flow.Ace with syngo MR XA70A | MAGNETOM Flow.Plus with syngo MR XA70A | MAGNETOM Flow.Neo with Syngo MR XB10 | |
| Magnet System | Yes, same as predicate, but with relocatable option (same as reference) | Yes | Yes | ||
| RF System | Yes, same as predicate device | Yes | Yes | ||
| Transmission technique – RF Body Coil | Yes, same as predicate device | Yes | Yes | ||
| Gradient System | Yes, same as predicate device, but with a new Gradient Configuration Upgrade from B60 to G60 | Yes | Yes | ||
| Patient Table | Yes, new compared to predicate, but same as reference: - BioMatrix Dockable Table with / without eDrive | Yes | Yes | ||
| Computer | Yes, same as predicate device | Yes | Yes | ||
| Coils | Yes, modified compared to predicate, but same as reference: - Comfort Sound for BM Head/Neck Coil | Yes | Yes |
Page 10
| Hardware | Subject Devices | Predicate Devices | Reference Device | ||
|---|---|---|---|---|---|
| MAGNETOM Flow.Ace with Syngo MR XB10 | MAGNETOM Flow.Plus with Syngo MR XB10 | MAGNETOM Flow.Ace with syngo MR XA70A | MAGNETOM Flow.Plus with syngo MR XA70A | MAGNETOM Flow.Neo with Syngo MR XB10 | |
| Other HW components | Yes, new compared to predicate: -Spine support respiratory (Cushion) as a part of BM Spine Coil Set 1.5T (including new surface material)Yes, new compared to predicate, but same as reference: - Comfort Sound Cushion | Yes | Yes |
Table 2. Software Features Comparison
| Hardware | Subject Devices | Predicate Devices | Reference Device | ||
|---|---|---|---|---|---|
| MAGNETOM Flow.Ace with Syngo MR XB10 | MAGNETOM Flow.Plus with Syngo MR XB10 | MAGNETOM Flow.Ace with syngo MR XA70A | MAGNETOM Flow.Plus with syngo MR XA70A | MAGNETOM Flow.Neo with Syngo MR XB10 |
Sequences
SE-based pulse sequence types
Yes, modified compared to predicate, but same as reference:
SE:
- with ID Gain
TSE:
- with Deep Resolve Boost improvement
- with Preview functionality for Deep Resolve Boost
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
- with ID Gain
TSE_DIXON:
- with ID Gain
HASTE:
- with Deep Resolve Boost (e.g. preview functionality)
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
SPACE:
- with "MTC Mode" improvement
- with Deep Resolve Boost (e.g. preview functionality)
- with Deep Resolve Sharp
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
BLADE:
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
| | | Yes | | Yes |
Page 11
GRE-based/Steady-State Pulse Sequence Types
Yes, modified compared to predicate, but same as reference:
FL3D_VIBE:
- with Deep Resolve Boost (e.g. preview functionality)
- with Deep Resolve Sharp
- with Compressed Sensing (CS-Vibe)
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
TurboFLASH (TFL):
- with BioMatrix Motion Sensor (SAMER)
GRE_PC:
- in-plane generalized auto calibrating parallel acquisition (GRAPPA)-based SMS formulation
| | | Yes | | Yes |
EPI-based Pulse Sequence Types
Yes, modified compared to predicate, but same as reference:
EP2D_DIFF:
- with Deep Resolve Boost (e.g. preview functionality)
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
RESOLVE:
- with SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
| | | Yes | | Yes |
Spectroscopy Pulse Sequence Types
Yes, same as predicate device | | Yes | | Yes |
Feature and Applications
Inline post-processing functions
Yes, modified compared to predicate, but same as reference:
- with Flip Angle Optimization (Lock TR and FA)
| | | Yes | | Yes |
Application Suites
Yes, same as predicate device | | Yes | | Yes |
myExam
Yes, same as predicate device | | Yes | | Yes |
Other Imaging Applications
Yes, modified compared to predicate, but same as reference:
- myExam Implant Suite
| | | Yes | | Yes |
Other Tim Suites
Yes, same as predicate device | | Yes | | Yes |
Visualization
Yes, same as predicate device | | Yes | | Yes |
Basic Post-Processing
Yes, same as predicate device | | Yes | | Yes |
Communication
Yes, same as predicate device | | Yes | | Yes |
Page 12
Application and post-processing
Yes, new compared to predicate, but same as reference:
- Open Workflow Framework
Yes, modified compared to predicate, but same as reference:
- Open Recon Framework
| | | Yes | | Yes |
Other Software Feature / Application
Yes, same as predicate device | | Yes | | Yes |
Software Platform and General Workflow
Yes, new compared to predicate, but same as reference:
- Eco Power Mode Pro
| | | Yes | | Yes |
Other Modifications / Minor Changes
Yes, same as predicate, but new claim introduced
- PETRA
Yes, modified compared to predicate, but same as reference:
- Off-Center Planning Support
- Marketing bundle "myExam Companion"
| | | Yes | | Yes |
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 | claim evidence | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices |
| Software verification and validation | new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| Biocompatibility | surface of applied parts | ISO 10993-1 |
| Electrical safety and electromagnetic compatibility (EMC) | complete system | IEC 60601-1-2 |
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 as claim evidence only. Clinical publications were referenced to provide information on the use of the following features and functions.
Page 13
| Feature / Function | Clinical Publication |
|---|---|
| BioMatrix Motion Sensor (SAMER) | [1] Polak D, Splitthoff DN, Clifford B, Lo W-C, Huang SY, Conklin J, Wald LL, Setsompop K, Cauley S: Scout accelerated motion estimation and reduction (SAMER); Magn Reason Med 87:163-178 (2022). https://doi.org/10.1002/mrm.28971[2] Lang M, Tabari A, Polak D, Ford J, Clifford B, Lo W-C, Manzoor K, Splitthoff DN, Wald LL, Rapalino O, Schaefer P, Conklin P, Cauley S, Huang SY: Clinical Evaluation of Scout Accelerated Motion Estimation and Reduction Technique for 3D MR Imaging in the Inpatient and Emergency Department Settings; Am J Neuroradiol 44:125-133 (2023). https://doi.org/10.3174/ajnr.A7777 |
| CS_VIBE | [3] Vreemann, S., Rodriguez-Ruiz, A., Nickel, D., Heacock, L., Appelman, L., van Zelst, J., Karssemeijer, N., Weiland, E., Maas, M., Moy, L., Kiefer, B., & Mann, R. M. (2017). Compressed Sensing for Breast MRI: Resolving the Trade-Off Between Spatial and Temporal Resolution. Investigative Radiology, 52(10), 574–582. https://doi.org/10.1097/rli.0000000000000384 |
| PETRA | [4] Grodzki DM, Jakob PM, Heismann B. Ultrashort echo time imaging using pointwise encoding time reduction with radial acquisition (PETRA). Magn Reson Med. 2012 Feb;67(2):510-8. doi: 10.1002/mrm.23017. Epub 2011 Jun 30. PMID: 21721039.[5] Li C, Magland JF, Zhao X, Seifert AC, Wehrli FW. Selective in vivo bone imaging with long-T2 suppressed PETRA MRI. Magn Reson Med. 2017 Mar;77(3):989-997. doi: 10.1002/mrm.26178. Epub 2016 Feb 24. PMID: 26914767. |
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 Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 conform to the following FDA recognized and international IEC, ISO and NEMA standards:
Page 14
| 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 |
| 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) | 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 | ANSI AAMI ISO |
12. Conclusion as to Substantial Equivalence
MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 have the same intended use and same basic technological characteristics as the respective predicate device systems, MAGNETOM Flow.Ace & MAGNETOM
Page 15
Flow.Plus with software syngo MR XA70A, 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 Flow.Ace & MAGNETOM Flow.Plus with software Syngo MR XB10 are substantially equivalent to the currently marketed MAGNETOM Flow.Ace & MAGNETOM Flow.Plus with software syngo MR XA70A (K250436, cleared on June 16, 2025).
§ 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.