Your MAGNETOM system is indicated for use as a magnetic 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.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

Device Description

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A includes new and modified hardware and software compared to the predicate device, MAGNETOM Sola with software syngo MR XA11A. A high level summary of the hardware and software is provided below:

Hardware

Computer
Nose Marker for Inline Motion Correction
Coils
BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and is based on the Body 18 coil, (cleared with K101347). It is a general purpose coil.
The BM Body 18 coil can be used with two different cables of different length; this capability was introduced with the BM Body 12 coil.

Software
Features and Applications

SMS for TSE DIXON: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon imaging.
GOLiver is a set of optimized pulse sequence for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type for the 1.5 T MR systems. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
RT Respiratory self-gating for FL3D VIBE: Non-contrast abdominal and thoracic examination in free breathing with reduced blur induced by respiratory motion.
i SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
SPACE with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
TSE MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.
TFL (3D MPRAGE), TSE and GRE with Inline Motion Correction: 3D -MPRAGE, TSE and GRE with Inline Motion Correction: Tracking of motion of the head during head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
EP SEG PHS: pulse sequence type EP SEG PHS, based on BEAT EPI and modified with a silent period that can be used by external devices/applications for synchronization with the MR imaging
GRE PHS: pulse sequence type GRE PHS, is a GRE pulse sequence type, modified to provide a silent period that can be used by external devices/applications for synchronization with the MR imaging.
GRE Proj: The GRE projection pulse sequence type "" allows the acquisition of 1-D projection data for different orientations.
GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is designed to provide consistent exam slots and to reduce the workload for the user in Knee MRI.
BEAT_interactive: The BEAT_Interactive pulse sequence type is a modification of the BEAT IRTTT pulse sequence type in order to interactively increase the slice thickness and switch on and off a magnetization pulse that the user can select prior to the measurement start.
EP2D SE MRE: As an alternative of greMRE, EP2D SE MRE pulse sequence type is based on single-shot EP2D_SE_MRE sequence. It offers acquisition of multiple slices in a single, short breath-hold, and it is more robust against signal dephasing effects while providing comparable relative stiffness values.
ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The feature is now available for 1-ch-systems and enables improved robustness to infolding artifacts from tissue from outside the excited reqion.
SPACE Flair Improvements: SPACE pulse sequence type offers a magnetization preparation mode for brain imaging with FLAIR contrast (FLuid Attenuated Inversion Recovery); improving the image quality of FLAIR images.
External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost correction acquisition method for diffusion imaging in the presence of fat.
MR Breast Biopsy Workflow improvements: The changes made to MR Breast Biopsy application target two areas: the improved readability of planning results and the ability to handle the planning of multiple biopsy targets.
GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time) GOBrain+ (adaptation of GOBrain pulse sequences)

Software / Platform

Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection via a share.
Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional communication with the MR scanner via a secure local network connection, supporting data transfer to and triggering of data acquisition from the 3rd party device. It enables the 3rd party client to control and edit a measurement program on the MR.
Table positioning mode: A new table positioning mode "FIX" is introduced which complements the existing table positioning modes ISO and LOC to support workflows in which the user needs to be in control of a defined Zposition at which measurements get executed.

Other Modifications and / or Minor Changes

MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Aera.
BM Body 12: For MR examinations of head and neck in situations where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution as what can be achieved with 4-channel Flex rf coils
Body 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4-channel Flex rf coils
UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4channel Flex rf coils
Broad band / narrow band online supervision: The broadband/narrowband supervision checks the correctness of the measurement values used for the SAR calculation. With syngo MR XA20A, the supervision cycle is reduced significantly.
LiverLab Dot Engine debundling: LiverLab is now offered separately as standalone workflow and is also still available as part of the Abdomen Dot Engine.
The 1.5T system MAGNETOM Altea is made available to the marked with software syngo MR XA20A.

AI/ML Overview

This document is a 510(k) summary for the Siemens MAGNETOM Sola, Altea, and Sola Fit MRI systems with software syngo MR XA20A. It outlines their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device for a Magnetic Resonance Diagnostic Device (MRDD). The testing described is largely for demonstrating the safety and performance of new and modified hardware and software features in comparison to the predicate. It is not a clinical study proving diagnostic accuracy of an AI algorithm, a typical scenario for the detailed acceptance criteria you requested. Therefore, many of your specific questions regarding AI algorithm performance (e.g., MRMC studies, ground truth for training data, effect size of human improvement with AI) are not applicable or not explicitly detailed in this type of 510(k) submission for an MRI system.

The "acceptance criteria" here relate more to the performance and safety of the MRI system itself, rather than diagnostic accuracy of an AI algorithm based on a specific clinical endpoint.

Acceptance Criteria and Reported Device Performance

The document presents the testing conducted to support the substantial equivalence of the new and modified hardware and software components of the MAGNETOM systems. The "acceptance criteria" are implied by the successful completion of these nonclinical tests and their demonstration that the device performs as intended and is equivalent to the predicate.

Table of Acceptance Criteria and Reported Device Performance (Implied from Nonclinical Tests):

Acceptance Criteria Category (Implied)	Specific Tests Performed	Reported Device Performance/Conclusion
Image Quality & Performance	Sample clinical images; Image quality assessments by sample clinical images (comparison with predicate features)	Results demonstrate the devices perform as intended. The new/modified features showed "equivalent safety and performance profile to that of the predicate device." "Clinical publications were referenced to provide information on the use of some features and functions."
Hardware Performance	Performance bench testing (for new/modified hardware)	Results demonstrate the devices perform as intended. The new/modified hardware showed "equivalent safety and performance profile to that of the predicate device."
Software Functionality & Safety	Software verification and validation (for new/modified software features)	Results demonstrate the devices perform as intended. The new/modified software features showed "equivalent safety and performance profile to that of the predicate device." Conforms to IEC 62304 ("Medical device software - Software life cycle processes").
Biocompatibility	Biocompatibility testing (surface of applied parts)	Conforms to ISO 10993-1. (Implies successful biocompatibility.)
Electrical, Mechanical, Safety	Electrical, mechanical, structural, and related system safety test (complete system)	Conforms to AAMI / ANSI ES60601-1 and IEC 60601-2-33 (implies successful safety performance).
EMC (Electromagnetic Compatibility)	Electrical safety and electromagnetic compatibility (EMC) (complete system)	Conforms to IEC 60601-1-2 (implies successful EMC performance).
Risk Management	Risk Management process per ISO 14971	Risk analysis in compliance with ISO 14971 was performed to identify and mitigate potential hazards.
Usability	Application of usability engineering per IEC 62366	Conforms to IEC 62366 (implies device is designed with usability in mind to minimize use errors).
Other MRI Standards	Acoustic Noise Measurement, Phased Array Coil Characterization, DICOM conformity	Conforms to NEMA MS 4, MS 9, PS 3.1 - 3.20 (implies compliance with relevant MRI system performance and interoperability standards).

Study Details (Based on Provided Text)

Given that this is a 510(k) for an MRI system with new/modified features, and not an AI diagnostic algorithm, the "study" is a collection of nonclinical tests.

Sample size used for the test set and the data provenance:
- The document states "Sample clinical images were provided" for image quality assessment. It does not specify the number of images or patients (sample size) used for these assessments.
- Data provenance (country of origin, retrospective/prospective) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Image quality assessments by sample clinical images," it's stated, "when interpreted by a trained physician, yield information that may assist in diagnosis."
- However, the number and qualifications of experts involved in the assessment of these sample clinical images for the purpose of the 510(k) submission are not specified. This is likely an internal verification step, not a formal clinical trial with external readers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of the nonclinical testing for device features, a formal adjudication process for "ground truth" (as expected for diagnostic performance studies) is not described. The assessments were likely internal comparisons to predicate performance.
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 MRMC study described. This 510(k) is for an MRI system, not an AI diagnostic algorithm. The improvements mentioned ("fast and efficient imaging," "reduce the workload") are theoretical benefits of the features themselves, not a quantified improvement in human reader performance with AI assistance. The document explicitly states "No additional clinical tests were conducted to support substantial equivalence for the subject devices."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes an MRI system, not a standalone AI algorithm. The software features are integrated into the system for image acquisition and processing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" as it pertains to clinical diagnostic accuracy is not explicitly used or established in this context. The "truth" for these nonclinical tests is based on the device meeting its engineering specifications, performing equivalently to the predicate, and producing images of acceptable quality when interpreted by a trained physician. The images themselves serve as the output, assessed against expected image quality parameters.
The sample size for the training set:
- Not applicable / Not specified. This document describes a medical device (MRI system) with software and hardware features, not a machine learning model that requires a "training set" in the common sense. Any internal development data used to refine pulse sequences or image reconstruction is not considered a "training set" in the context of AI regulatory submissions.
How the ground truth for the training set was established:
- Not applicable / Not specified. See point 7.

Summary

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February 28, 2020

Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Professional 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355

Re: K192496

Trade/Device Name: MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: January 23, 2020 Received: January 28, 2020

Dear Cordell Fields:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, PhD. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192496

Device Name

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit

Indications for Use (Describe)

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

Traditional Premarket Notification 510(k)

September 10, 2019

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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.40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration Number: 2240869
Date Prepared:	September 9, 2019
Manufacturer:	Siemens Healthcare GmbHHenkestrasse 12791052 ErlangenGermanyRegistration Number: 3002808157For MAGNETOM Sola andMAGNETOM Altea:Siemens Shenzhen MagneticResonance LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number: 3004754211
2. Contact Information
	Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USA
Phone:	(610) 448-6469
Fax:	(610) 448-1787
E-mail:	cordell.fields@siemens-healthineers.com

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.

3. Device Name and Classification

Device name:

Trade name:

Classification Name:

Classification Panel: CFR Code: Classification: Product Code:

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 . Primary: LNH Secondary: LNI, MOS

4. Legally Marketed Predicate Device

Trade name: 510(k) Number: Clearance Date:

Classification Name:

Classification Panel: CFR Code: Classification: Product Code:

MAGNETOM Sola MAGNETOM Sola K181322, K182129, cleared October 5, 2018 (K181322), October 12, 2018 (K182129) Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 = Primary: LNH Secondary: LNI, MOS

5. Intended Use

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

Your 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

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.

images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Your 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

Hardware

Computer
Nose Marker for Inline Motion Correction

Coils

BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and is based on the Body 18 coil, (cleared with K101347). It is a general purpose coil.
The BM Body 18 coil can be used with two different cables of different length; this capability was introduced with the BM Body 12 coil.

Software

Features and Applications

SMS for TSE DIXON: Simultaneous excitation and acquisition of multiple । slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon imaging.
GOLiver is a set of optimized pulse sequence for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS) । functionality is now available for TOF MRA within the BEAT pulse sequence type for the 1.5 T MR systems. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
RT Respiratory self-gating for FL3D VIBE: Non-contrast abdominal and । thoracic examination in free breathing with reduced blur induced by respiratory motion.
i SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for readout-

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/6/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.

segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).

SPACE with Compressed Sensing (CS): The Compressed Sensing (CS) । functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of i patients with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
TSE MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.
TFL (3D MPRAGE), TSE and GRE with Inline Motion Correction: 3D -MPRAGE, TSE and GRE with Inline Motion Correction: Tracking of motion of the head during head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
EP SEG PHS: pulse sequence type EP SEG PHS, based on BEAT EPI i and modified with a silent period that can be used by external devices/applications for synchronization with the MR imaging
GRE PHS: pulse sequence type GRE PHS, is a GRE pulse sequence type, i modified to provide a silent period that can be used by external devices/applications for synchronization with the MR imaging.
GRE Proj: The GRE projection pulse sequence type "" allows the acquisition of 1-D projection data for different orientations.
GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with । Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is designed to provide consistent exam slots and to reduce the workload for the user in Knee MRI.
BEAT_interactive: The BEAT_Interactive pulse sequence type is a । modification of the BEAT IRTTT pulse sequence type in order to interactively increase the slice thickness and switch on and off a magnetization pulse that the user can select prior to the measurement start.
EP2D SE MRE: As an alternative of greMRE, EP2D SE MRE pulse i sequence type is based on single-shot EP2D_SE_MRE sequence. It offers acquisition of multiple slices in a single, short breath-hold, and it is more robust against signal dephasing effects while providing comparable relative stiffness values.
ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted i imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The feature is now available for 1-ch-systems and enables improved robustness to infolding artifacts from tissue from outside the excited reqion.

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a pattern of orange dots.

SPACE Flair Improvements: SPACE pulse sequence type offers a maqnetization preparation mode for brain imaging with FLAIR contrast (FLuid Attenuated Inversion Recovery); improving the image quality of FLAIR images.
External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost i correction acquisition method for diffusion imaging in the presence of fat.
। MR Breast Biopsy Workflow improvements: The changes made to MR Breast Biopsy application target two areas: the improved readability of planning results and the ability to handle the planning of multiple biopsy targets.
GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time) । GOBrain+ (adaptation of GOBrain pulse sequences)

Software / Platform

Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection i via a share.
Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional communication with the MR scanner via a secure local network connection, supporting data transfer to and triggering of data acquisition from the 3rd party device. It enables the 3rd party client to control and edit a measurement program on the MR.
Table positioning mode: A new table positioning mode "FIX" is introduced which complements the existing table positioning modes ISO and LOC to support workflows in which the user needs to be in control of a defined Zposition at which measurements get executed.

Other Modifications and / or Minor Changes

MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which i is the result of an upgrade from a MAGNETOM Aera.
BM Body 12: For MR examinations of head and neck in situations where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution as what can be achieved with 4-channel Flex rf coils
Body 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4-channel Flex rf coils
UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and । neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4channel Flex rf coils
। Broad band / narrow band online supervision: The broadband/narrowband supervision checks the correctness of the measurement values used for the

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/8/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

SAR calculation. With syngo MR XA20A, the supervision cycle is reduced significantly.

LiverLab Dot Engine debundling: LiverLab is now offered separately as standalone workflow and is also still available as part of the Abdomen Dot Engine.
The 1.5T system MAGNETOM Altea is made available to the marked with software syngo MR XA20A.

7. Substantial Equivalence

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A are substantially equivalent to the following predicate device:

Predicate Device	FDA Clearance Numberand Date	ProductCode	Manufacturer
MAGNETOM Sola withsyngo MR XA11A	K181322, K182129,cleared October 5, 2018(K181322), October 12,2018 (K182129)	LNHLNI, MOS	Siemens HealthcareGmbH

MAGNETOM Sola. MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A includes hardware and software already cleared on the following reference devices:

Reference Devices	FDA Clearance Numberand Date	ProductCode	Manufacturer
MAGNETOM Aera withsoftware syngo MR E11C-AP01	K182299cleared October 26, 2018	LNH,LNI, MOS	Siemens HealthcareGmbH
MAGNETOM Aera withsyngo MR E11C-AP02	K163312cleared January 27, 2017	LNH, LNI,MOS	Siemens AG / SiemensHealthcare GmbH
MAGNETOM Aera withsyngo MR E11C	K153343cleared April 15, 2016	LNH	Siemens AG / SiemensHealthcare GmbH
MAGNETOM Vida withsoftware syngo MR XA11B	K183254cleared January 18, 2019	LNH,LNI, MOS	Siemens HealthcareGmbH
MAGNETOM Skyra withsyngo MR D13C	K123510cleared May 17, 2013	LNH	Siemens AG
MAGNETOM Lumina withsyngo MR XA11B	K183244cleared January 24, 2019	LNH,LNI, MOS	Siemens HealthcareGmbH

Technoloqical Characteristics 8.

The subject devices, MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A, are substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.

Traditional Premarket Notification 510(k)

Siemens MR Systems: MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit (1.5T) with new Software syngo MR XA20A

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September 9, 2019

Image /page/9/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.

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

While there are some differences in technological characteristics between the subject devices and predicate device, including new and modified hardware and software, these differences have been tested and the conclusions from the nonclinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.

9. Nonclinical Tests

The following performance testing was conducted on the subject devices.

Performance Test	Tested Hardware or Software	Source/Rationale for test
Sample clinical images	coils, new and modifiedsoftware features	Guidance for Submission ofPremarket Notifications forMagnetic ResonanceDiagnostic Devices
Image quality assessments bysample clinical images. Insome cases a comparison ofthe image quality / quantitativedata was made.	- new / modified pulsesequence types.- comparison images betweenthe new / modified featuresand the predicate devicefeatures
Performance bench test	mainly new and modifiedhardware
Software verification andvalidation	mainly new and modifiedsoftware features	Guidance for the Content ofPremarket Submissions forSoftware Contained in MedicalDevices
Biocompatibility	surface of applied parts	ISO 10993-1
Electrical, mechanical,structural, and related systemsafety test	complete system	- AAMI / ANSI ES60601-1- IEC 60601-2-33
Electrical safety andelectromagnetic compatibility(EMC)	complete system	IEC 60601-1-2

The results from each set of tests demonstrate that the devices perform as intended and are therefore substantially equivalent to the predicate device to which it has been compared.

10. Clinical Tests

MR XA20A

No additional clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided. Clinical publications were referenced to provide information on the use of some features and functions.

Traditional Premarket Notification 510(k)

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Image /page/10/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

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 Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A conform to the following FDA recognized and international IEC, ISO and NEMA standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and date	StandardsDevelopmentOrganization
19-4	General	Medical electrical equipment -Part 1: general requirements forbasic safety and essentialperformance	ES60601-1:2005/(R) 2012and A1:2012	AAMI / ANSI
19-8	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests	60601-1-2, Ed.4.0:2014-02	IEC
12-295	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis	60601-2-33, Ed.3.2:2015	IEC
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971, Ed. 2:2007-10	ISO
5-114	General	Medical devices - Application ofusability engineering to medicaldevices	62366, Ed.1.0:2015	AAMIANSIIEC
13-79	Software	Medical device software -Software life cycle processes	62304:2015-06	AAMIANSIIEC

Traditional Premarket Notification 510(k)

September 9, 2019

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Image /page/11/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

12-232	Radiology	Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices	MS 4:2010	NEMA
12-288	Radiology	Characterization of PhasedArray Coils for DiagnosticMagnetic Resonance Images(MRI)	MS 9:2008	NEMA
12-300	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology	PS 3.1 - 3.20:2016	NEMA
2-220	Biocompatibility	Biological evaluation of medicaldevices - Part 1: evaluation andtesting within a riskmanagement process(Biocompatibility)	10993-1:2009	AAMIANSIISO

12. Conclusion as to Substantial Equivalence

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A have the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Sola with syngo MR XA11A. While there are some differences in technilogical characteristics/features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference devices.

Siemens believes that MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A are substantially equivalent to the currently marketed predicate device MAGNETOM Sola with software syngo MR XA11A (K181322, K182129, cleared on October 5, 2018 (K181322), October 12, 2018 (K182129)).

Traditional Premarket Notification 510(k)

September 9, 2019

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.