MAGNETOM Viato.Mobile

K240608 · Siemens Medical Solutions USA, Inc. · LNH · Mar 29, 2024 · Radiology

Device Facts

• Record ID: K240608
• Device Name: MAGNETOM Viato.Mobile
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Mar 29, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 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.

Device Story

MAGNETOM Viato.Mobile is a magnetic resonance diagnostic device (MRDD) used in clinical settings by trained physicians to acquire and interpret cross-sectional images, spectroscopic images, and spectra of the head, body, or extremities. The system utilizes magnetic resonance imaging (MRI) technology to display internal structures and functions, aiding in clinical diagnosis. This version introduces a new XQ gradient coil and gradient power amplifier, replacing the XJ gradient system found in the predicate. The device supports interventional procedures when used with MR-compatible accessories like biopsy needles and in-room displays. Healthcare providers use the generated images to inform clinical decision-making. The system is designed for professional use, ensuring patient benefit through non-invasive diagnostic visualization.

Clinical Evidence

No clinical data or clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including verification and validation of the new hardware and system-level electrical safety and electromagnetic compatibility (EMC) testing per IEC 60601-1-2.

Technological Characteristics

Magnetic resonance diagnostic device; utilizes XQ gradient coil and gradient power amplifier. Conforms to IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-33 (MR safety), and NEMA MS 4 (Acoustic noise). Software: syngo MR XA51A. Operates via standard MR imaging principles. Sterilization not applicable; device is for professional clinical use.

Indications for Use

Indicated for patients requiring MR diagnostic imaging of head, body, or extremities; produces cross-sectional images, spectroscopic images, and spectra to assist in diagnosis; usable for interventional procedures with MR-compatible devices.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• MAGNETOM Viato.Mobile (K232482)

Reference Devices

• MAGNETOM Sola Fit with software syngo MR XA51A (K221733)

Submission Summary (Full Text)

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March 29, 2024

Siemens Medical Solutions USA, Inc. Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355

Re: K240608

Trade/Device Name: MAGNETOM Viato.Mobile Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 29, 2024 Received: March 4, 2024

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.

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).

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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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D. R. Katz

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

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# Indications for Use

Submission Number (if known)

K240608

Device Name

MAGNETOM Viato.Mobile

#### Indications for Use (Describe)

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 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 vield 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92.

# 1. General Information

| Establishment: | Siemens Medical Solutions USA, Inc.<br>40 Liberty Boulevard<br>Malvern, PA 19355, USA<br>Registration Number: 2240869 |
|----------------|-----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 29, 2024 |
| Manufacturer: | Siemens Healthcare GmbH<br>Henkestrasse 127<br>91052 Erlangen<br>Germany<br>Registration Number: 3002808157 |

#### 2. Contact Information

Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: [phone] E-mail: [e-mail]

#### Device Name and Classification 3.

| Device/ Trade name: | MAGNETOM Viato.Mobile |
|-----------------------|---------------------------------------------|
| 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 |

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#### 4. Legally Marketed Predicate Device

| Trade name: | MAGNETOM Viato.Mobile |
|-----------------------|--------------------------------------------|
| 510(k) Number: | K232482 |
| Clearance Date: | September 6, 2023 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH<br>Secondary: LNI, MOS |

## 5. Intended Use / Indications for Use

The indications for use for the subject device is the same as the predicate device:

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 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.

## 6. Device Description

MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system. A highlevel summary of the modified hardware is provided below:

### Hardware

Modified Hardware

- Gradient Coil
- Gradient Power Amplifier

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# 7. Substantial Equivalence

MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system is substantially equivalent to the following predicate device:

| Predicate Device | FDA Clearance Number<br>and Date | Product Code | Manufacturer |
|----------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Viato.Mobile<br>with syngo MR XA51A | K232482,<br>cleared September 6, 2023 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |

MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes hardware already cleared on the following reference device:

| Reference device | FDA Clearance Number<br>and Date | Product<br>Code | Manufacturer |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola Fit with<br>software syngo MR XA51A | K221733,<br>cleared December 13, 2022 | LNH<br>LNI, MOS | Siemens Healthcare<br>GmbH |
| Please note: the XQ gradient<br>system, as part of MAGNETOM<br>Sola Fit with software syngo MR<br>XA51A, is the reference device<br>related to modifications performed<br>to provide a XQ gradient system<br>option. | | | |

#### Comparison of technological Characteristics with the Predicate Device 8.

The subject device, MAGNETOM Viato.Mobile with software syngo MR XA51A, and XQ gradient system is substantially equivalent to the predicate device with regard to the intended use, operational environment, programming language, operating system and performance.

The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.

There are no differences in technological characteristics between the subject device and predicate device, but new hardware, these differences have been tested and the conclusion from the non-clinical data suggests that the system bears an equivalent safety and performance profile to that of the predicate device.

# 9. Nonclinical Tests

The following performance testing was conducted on the subject device.

| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------|
| Performance bench test | new hardware | Guidance for Submission of<br>Premarket Notifications for<br>Magnetic Resonance<br>Diagnostic Devices |

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| Verification and validation | new hardware | Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in Medical<br>Devices |
|-----------------------------------------------------------------|-----------------|------------------------------------------------------------------------------------------------------|
| Electrical safety and<br>electromagnetic compatibility<br>(EMC) | complete system | IEC 60601-1-2 |

The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.

## 10. Clinical Tests / Publications

No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device.

# 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 Healthcare GmbH 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 Viato.Mobile with software syngo MR XA51A and XQ gradient system conforms to the following FDA recognized and international IEC, ISO and NEMA standards:

| Recognition Product<br>Number | Area | Title of Standard | Reference<br>Number and date | Standards<br>Development<br>Organization |
|-------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 19-4 | General II<br>(ES/EMC) | Medical electrical equipment -<br>Part 1: General requirements for<br>basic safety and essential<br>performance (IEC 60601-<br>1:2005, MOD) | ES60601-<br>1:2005/(R)2012<br>and A1:2012,<br>C1:2009/(R)2012<br>and<br>A2:2010/(R)2012<br>(Consolidated Text) | ANSI AAMI |

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| 19-8 | General | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests | 60601-1-2, Ed.<br>4.0:2014 | IEC |
|--------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------|
| 12-295 | Radiology | Medical electrical equipment -<br>Part 2-33: Particular<br>requirements for the basic<br>safety and essential<br>performance of magnetic<br>resonance equipment for<br>medical diagnosis | 60601-2-33, Ed.<br>3.2:2015 | IEC |
| 5-125 | General I<br>(QS/ RM) | Medical devices - Application of<br>risk management to medical<br>devices | 14971 Third Edition<br>2019-12 | ISO |
| 12-232 | Radiology | Acoustic Noise Measurement<br>Procedure for Diagnosing<br>Magnetic Resonance Imaging<br>Devices | MS 4:2010 | NEMA |

# 12. Conclusion as to Substantial Equivalence

MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Viato.Mobile with syngo MR XA51A and XJ gradient system, with respect to the magnetic resonance features and functionalities. There are no differences in technical features compared to the predicate device, but new hardware. The resulting differences have been tested and the conclusions from all verification and validation data suggest that the system bears an equivalent safety and performance profile to that of the predicate device and reference device.

Siemens believes that MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system is substantially equivalent to the currently marketed device MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system(K232482, cleared on September 6, 2023).