K Number

Device Name

MAGNETOM Sola

Manufacturer

Siemens Medical Solutions USA, Inc.

Date Cleared

2018-10-05

(140 days)

Product Code

LNH LNI MOS

Regulation Number

892.1000

Intended Use

Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 inages 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. 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.

Device Description

MAGNETOM Sola with software syngo MR XA11A is similar to the previous cleared predicate device MAGNETOM Aera with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Aera. A high level summary of the hardware and software changes is included below.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K153343

Reference Devices

K170396, K173617, K173592, K150843, K163312

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software changes without mentioning AI/ML capabilities.

Therapeutic

No
The device is indicated for use as a magnetic device that produces images and/or spectra to assist in diagnosis, which is for diagnostic purposes, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the images and/or spectra produced by the system, when interpreted by a trained physician, "yield information that may assist in diagnosis." Additionally, the "Summary of Performance Studies" mentions "Magnetic Resonance Diagnostic Devices."

SaMD (Software as a Medical Device)

The device description explicitly states that the device includes "new and modified hardware and software" and mentions hardware changes.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is an in-vivo diagnostic process, meaning it's performed on a living organism.
IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on such samples.
Device Description: The description focuses on the hardware and software of an MRI system, which is used for imaging the body directly.
Input Imaging Modality: The input modality is Magnetic Resonance (MR), which is an in-vivo imaging technique.

The information provided describes a Magnetic Resonance Diagnostic Device (MRDD), which is a type of medical device used for in-vivo imaging and diagnosis, not an in-vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LNH, LNI, MOS

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance (MR)

Anatomical Site

head, body, or extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Tests:

Sample clinical images were taken in particular for the coils, as well as for new and modified software features and modified features in the pulse sequence types.
Image quality assessments of all new/modified pulse sequence types and algorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
Results: The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.

Clinical Tests:
A clinical study of 36 individuals was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images were provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document. Clinical publications were referenced to provide information on the use of some features and functions.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K153343

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K170396, K173617, K173592, K150843, K163312

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

October 5, 2018

Siemens Medical Solutions USA, Inc. Cordell Fields Regulatory Specialist 65 Valley Stream Parkway 65-1A Malvern, Pennsylvania 19355

Re: K181322

Trade/Device Name: MAGNETOM Sola Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: September 20, 2018 Received: September 21, 2018

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

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K181322

Device Name MAGNETOM Sola

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 displays 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)

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510(k) Summary Section 5

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

I. General Information

Establishment	Siemens Medical Solutions USA, Inc.
	40 Liberty Boulevard
	Mail Code 65-1A
	Malvern, PA 19355, USA
Registration Number:	2240869

May 17, 2018 Date Prepared
Manufacturer Siemens Healthcare GmbH Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157
Contact Person Cordell L. Fields, Esq. Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. Cordell.Fields@siemens-healthineers.com
Device Name MAGNETOM Sola
Trade Name MAGNETOM Sola
Classification Name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology CFR Code: 21 CFR § 892.1000 Classification: Class II Primary: LNH, Secondary: LNI, MOS Product Code:

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The indications for use for the subject device are the same as the predicate device and are as follows:

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 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.

Device Description

Hardware

New Hardware

Main components such as:
- maqnet -
- gradient coil –
- patient table (fixed and mobile)
New coils: -
- Body Coil -
- BM Head/Neck 20 -
- BM Spine 48 -
- BM Spine 32 -
- UltraFlex Large 18 -
- UltraFlex Small 18 -
- Shoulder Shape 16 -
- TX/RX Knee 18 -

-Other components such as:
- helium compressor -
- cover includes new touch displays and redesigned control island
- computers and monitor -
- Respiratory Sensors (respiratory sensor loops) -
- camera -
- -Multi-Channel Interface

Modified Hardware

main components such as gradient power amplifier and patient communication unit
other components such as RF power amplifier, magnet supervision, electronic cabinet and measurement control components

Software

New Features and Applications

। SliceAdiust (framework for pulse sequence types which allows applying adjustment settings dynamically to measured sub-volumes during the measurement.)
Whole-Body Dot Engine (supports multi-region examinations with consistent settings for spatial resolution, image contrast, and breath-hold capacity)
Compressed Sensing GRASP-VIBE (conduct dynamic contrast-enhanced abdominal exams in free breathing)
CoilShim (reduces patient induced strongly localized B0 inhomogeneities by generating the respective anatomy-specific B0 field with local shim coil elements integrated in the local Rx coil BM Head/Neck 20
GOKnee3D (examination which comprises the AutoAlign knee localizer and two SPACE with CAIPIRINHA sequences to support fast high-resolution 3D exams of the knee)
SPACE with CAIPIRINHA (3D SPACE pulse sequence type now offers the iPAT mode CAIPIRINHA)
Respiratory Sensor Support (support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)
MRSim / Synthetic CT (provides MR pulse sequences for the creation of Synthetic CT images based on the MR image input)
। Cardiac Dot Flow Add-In (extension of Cardiac Dot Engine to support blood flow measurements)

PCASL mode (extension of ASL pulse sequence types by a new blood labeling mode)
SMS in TSE (Simultaneous Multi Slice (SMS) support for TSE)

New Software / Platform

Software platform (new software version syngo MR XA11A based on the Numaris/X software which combines the software of the predicate device and the reference device with modifications and extensions as well as changed structure and design of the user interface and changed post processing integration.)
General workflow (scanning tab-card / left-hand side (LHS) and viewing and processing tab-card / right-hand side (RHS) concept with single / dual monitor workflow where patient handling and scanning is separated from post-processing and data handling. The scanning tab-card / "LHS" contains scan-related elements such as the Scheduler and scan UI and displays the inline processed images. At the viewing and processing tab-card / on the "RHS" additional results can be generated in the form of basic and advanced post-processing including data handling and result distribution.)
User role concept (five user roles with different rights)
Distribution step (allows the selection of data sets for archiving and DICOM transfer within MR View&GO)
4D Viewing (allows the visualization of 4D data such as different phases, bvalues or echoes of one DICOM series within MR View&GO and allows temporal (phase navigation in 4D data sets) and spatial scrolling.)
Launcher Step (starts an advanced application as a viewing and processing tabcard / on the RHS)
Multiframe DICOM format (now available in addition with improvements in performance, application support, navigation and data interchange.)
Touch positioning (Select&GO 2.0) (to position the exam region in the isocenter by using the touch displays integrated in the system cover. Select&GO 2.0 has been extended to additional body area positions if dedicated coils are plugged in)

Modified Features and Applications

Compressed Sensing Cardiac Cine (An option to enable Compressed Sensing Cardiac Cine is integrated into the BEAT pulse sequence type. The total acceleration factor is a user-interface parameter that controls the degree of kspace under-sampling. Compressed Sensing Cardiac Cine can be performed in sinqle-shot and in multi-shot mode.)

RetroGating (Compressed Sensing Cardiac Cine acquisitions which split the data acquisition over multiple heartbeats can now be configured to perform complete sampling of the cardiac cycle without prior definition of an acquisition window. Combination with arrhythmia rejection is possible.)
Dixon fat/water separation (improvement for a more robust assignment of local fat and water regions to the respective image)
Pre-Scan-Normalize (Improvements with the goal to correct MRI images for local coil sensitivity variations and to generate homogenous MRI images. Three different matrix sizes are available now.)
iPAT / TSE Reference Scan (Improvements in the VIBE and in the HASTE pulse sequence types to improve the image quality. Changes in the VIBE pulse sequence type concern the k-space reordering, the external GRE reference scan and the minimal slice oversampling. Changes in the HASTE, TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)
HeartFreeze (extended to support multiple repeats and averaging of the same slice acquired at the same phase of the cardiac cycle in combination with nonselective inversion recovery imaging)
Care Bolus in Angio Dot Engine (workflow support for bolus administration (bolus detection))
MRCP in SPACE (improvement of the image quality for MR Cholangiopancreatography (MRCP) acquisitions based on the SPACE pulse sequence type)
MR Elastography (Replacement of existing masking by a masking that is performed on the pre-scan images used also within the pre-scan normalize (PSN) functionality. Optimization of pulse sequence type timing. Changes in MEG time period (no longer fixed to the wavelength of the MEG and also implementation of a reduced MEG period))

Modified (general) Software / Platform

Scheduler (two components (Patient Registration and Scheduler) consolidated.)
Table Positioning Mode (Automated movement of table provided on examination level so that the scan is performed in the magnet isocenter. Additionally the "LocalRange" positioning mode can be used for smaller regions like e.g. the heart or the brain.)
Spectroscopy Add-in (enables planning on non-distortion corrected images for spectroscopy.)

MR View&GO (For quality assurance, image viewing, basic post-processing, printing and result distribution. The functionality is provided in workflow steps which provide quidance, allow independent work and do not require any reloading of data. Addition of Mosaic View (view mode to scroll through dimensions instead of space) and 4D Movie Toolbar (movie toolbar is usable to navigate through the 4th dimension))
Prior Handling (for the display of available priors)
System Start and Shutdown (improvements with a System Start Timer and shutdown unattended by the user)
Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)

Other Modifications and / or Minor Changes

SAR Assistant (two additional options for selection)
Noise masking (to remove the noise floor in outer regions)
MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)
MAGNETOM Sola Cardiovascular Edition marketing bundle (bundle of components for cardiovascular MR imaging)
Siemens "BioMatrix" (BioMatrix consists of three core technologies, Sensors, Tuners and Interfaces, all of which addressing different aspects of patient biovariability.)
Siemens "Healthineers" (new Siemens brand)
Improved Adjustments (frequency adjustment optimized for more reliable water peak detection, and FastView adjustments extended to be available for all kind of data selectable in the user interface)
Cooling Cabinet (increased cooling capacity and improvements)
BEAT IRTTT (extends BEAT IRT sequence with a multi-slice functionality and introduces some parameters. "TTT" stands for the extension of BEAT IRT to three dimensions)
Vacuum pump (automatic switching mechanism)
teamplay Protocols Interface (interface to support external pulse sequences management systems)
Unilateral Hip (added in Large Joint Dot Engine) (user workflow optimized, since information/settings from the patient registration are taken)

Image /page/9/Picture/1 description: The image shows the word "SIEMENS" in all capital letters. The letters are a teal color. The background is white.

GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)
Asymmetric saturation pulses (support for reqional saturation with an asymmetric shape has been added for BOLD imaging)
CP Mode modification ("RF Transmit Mode" is provided as part of the patient registration based on IEC 60601-2-33)
MR Breast Biopsy (support of breast coils changed)

Technological Characteristics

MAGNETOM Sola with software syngo MR XA11A has different technological characteristics than the predicate device MAGNETOM Aera (K153343; cleared April 15, 2016).

The subject device is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.

MAGNETOM Sola conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

While MAGNETOM Sola offers new and modified software with respect to the predicate device systems, MAGNETOM Sola has different technological characteristics than the predicate device systems. Additionally, this submission includes new and modified hardware including new coils.

Nonclinical Tests

The following performance testing was conducted on the subject device

। Sample clinical images were taken in particular for the coils, as well as for new and modified software features and modified features in the pulse sequence types.
Image quality assessments of all new/modified pulse sequence types and algorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016

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

Clinical Tests

A clinical study of 36 individuals was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.

No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images were provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document. Clinical publications were referenced to provide information on the use of some features and functions.

Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Sola with software syngo MR XA11A conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following table.

Image /page/11/Picture/0 description: The image features the word "SIEMENS" in a bold, sans-serif font. The color of the text is a vibrant teal. The letters are evenly spaced and appear to be horizontally aligned.

| Recognition
Number | Product
Area | Title of Standard and date | Standards
Development
Organization |
|-----------------------|-------- | 19-4 | General part 1: general requirements for
basic safety and essential
performance 1:2005/(R) 2012
and A1:2012 | AAMI / ANSI | 19-8 | General Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests | 60601-1-2 Edition
4.0:2014-02 | IEC | 12-295 | Radiology Part 2-33: Particular
requirements for the basic safety
and essential performance of
magnetic resonance equipment
for medical diagnosis 3.2:2015 | IEC | 5-40 | General risk management to medical
devices edition 2007-10 | ISO | 5-96 | General usability engineering to medical
devices 2015 | AAMI
ANSI
IEC |
| 13-32 | Software Software life cycle processes ANSI
IEC |
| 12-232 | Radiology Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | 12-288 | Radiology Array Coils for Diagnostic
Magnetic Resonance Images
(MRI) | 12-300 | Radiology Communications in Medicine
(DICOM) Set 03/16/2012
Radiology (2016) | NEMA | 2-156 bility | biological evaluation devices - part 1: evaluation and
testing within a risk management
process (Biocompatibility) 2013 | AAMI
ANSI
ISO | | Reference Number
--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| Medical electrical equipment -
| ES60601-
|
| Medical electrical equipment -
|
| Medical electrical equipment -
| 60601-2-33 Ed.
|
| Medical devices - Application of
| 14971 Second
|
| Medical devices - Application of
| 62366 Edition 1.0
| Medical device software -
| 62304:2006 | AAMI
| Acoustic Noise Measurement
| MS 4-2010 | NEMA |
| Characterization of Phased
| MS 9-2008 | NEMA |
| Digital Imaging and
| PS 3.1 - 3.20
|
| Biocompati
of medical
| 10993-1:2009/(R)

Substantial Equivalence

MAGNETOM Sola with software syngo MR XA11A includes most of the features of the predicate device and additional new and modified hardware and software as noted above.

| Predicate Device | FDA Clearance
Number and Date | Product
code | Manufacturer |
|----------------------------------------------------------------------------|-----------------------------------------------------------|-----------------|--------------------------------------------|
| MAGNETOM Aera with syngo
MR E11C | K153343,
cleared April 15,
2016 | LNH
LNI,MOS | Siemens AG /
Siemens Healthcare
GmbH |
| Reference Devices | FDA Clearance
Number and Date | Product
code | Manufacturer |
| MAGNETOM Vida with software
syngo MR XA10A | K170396,
cleared June 14,
2017 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| Compressed Sensing GRASP-
VIBE for MAGNETOM Vida with
syngo MR XA10A | K173617,
cleared March 30,
2018 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| MAGNETOM Aera with syngo
MR E11C-AP04 | K173592,
cleared February
13, 2018 | LNH
LNI,MOS | Siemens Healthcare
GmbH |
| syngo.via VB30A
based on syngo.via VB10A | syngo.via VB10A:
K150843,
cleared April 24,
2015 | LLZ | Siemens Healthcare
GmbH |
| MAGNETOM Aera with syngo
MR E11C-AP02 | K163312,
cleared January
27, 2017 | LNH
LNI,MOS | Siemens Healthcare
GmbH |

Conclusion as to Substantial Equivalence

MAGNETOM Sola with software syngo MR XA11A has the same intended use and different technological characteristics than the predicate device system, MAGNETOM Aera with syngo MR E11C, with respect to the magnetic resonance features and functionalities. While there are some technical features that vary with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the features with different technological characteristics from the predicate device bear an equivalent safety and performance profile as that of the predicate device and the reference devices.

Therefore the subject device is substantially equivalent to the predicate device.

In summary, MAGNETOM Sola has similar functionalities of the predicate device and based on the aforementioned information, does not introduce any new issues of safety

or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Sola with software syngo MR XA11A does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Aera with software syngo MR E11C (K153343, cleared on April 15, 2016).