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 that displays the internal structure and/or function of the head, body, or extremittes. 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 mages 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 Vida with software syngo MR XA10A is similar to the previous cleared predicate device MAGNETOM Skyra with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Skyra.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MAGNETOM Vida device, based on the provided text:

Preamble: It's important to note that this document is a 510(k) summary for a premarket notification for a Class II medical device (Magnetic Resonance Diagnostic Device). The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute efficacy in a clinical setting in the same way a PMA (Premarket Approval) might require. Therefore, the "acceptance criteria" and "device performance" are primarily focused on meeting established standards and showing that changes do not negatively impact safety or effectiveness compared to the predicate.

Acceptance Criteria and Reported Device Performance

The general acceptance criteria are that the device performs as intended and is "substantially equivalent" to the predicate device, especially regarding safety and effectiveness. The specific performance reported largely revolves around conformance to recognized standards and successful completion of verification and validation.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Standards	Reported Device Performance
PNS (Peripheral Nerve Stimulation) Threshold	Set PNS threshold level required by IEC 60601-2-33 based on nerve stimulation thresholds.	A clinical study successfully determined nerve stimulation thresholds, and these parameters were used to set the PNS threshold level in accordance with IEC 60601-2-33.
Image Quality Assessment	Assessment for all new/modified pulse sequence types and algorithms; comparison to predicate features where applicable.	Image quality assessments were completed for all new/modified pulse sequence types and algorithms. Comparisons were made between new/modified features and predicate features in some cases.
Software Verification & Validation	Conformance to FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Software verification and validation testing was completed in accordance with the specified FDA guidance document.
Performance Tests	Conformance to FDA guidance document: "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016.	Performance tests were completed in accordance with the specified FDA guidance document.
Risk Management	Risk analysis in compliance with ISO 14971:2007 (to identify and mitigate potential hazards).	Risk management was ensured via a risk analysis compliant with ISO 14971:2007. Risks are controlled via hardware/software development, testing, and labeling.
Electrical & Mechanical Safety	Conformance to IEC 60601-1 series (to minimize electrical and mechanical risk).	Siemens adheres to the IEC 60601-1 series and other recognized industry practices and standards.
Usability Engineering	Conformance to IEC 62366 Edition 1.0 2015.	Conforms to IEC 62366.
Software Life Cycle Processes	Conformance to IEC 62304:2006.	Conforms to IEC 62304:2006.
Acoustic Noise Measurement	Conformance to NEMA MS 4-2010.	Conforms to NEMA MS 4-2010.
Phased Array Coil Characterization	Conformance to NEMA MS 9-2008.	Conforms to NEMA MS 9-2008.
Digital Imaging & Communications in Medicine	Conformance to NEMA PS 3.1 - 3.20 (2016) (DICOM).	Conforms to NEMA PS 3.1 - 3.20 (2016).
Biocompatibility	Conformance to ISO 10993-1:2009/(R) 2013.	Conforms to ISO 10993-1:2009/(R) 2013 for biocompatibility.
Overall Substantial Equivalence	Device does not raise new questions of safety or effectiveness compared to the predicate device, MAGNETOM Skyra with syngo MR E11C (K153343).	Based on all verification and validation data, new/modified features bear an equivalent safety and performance profile to the predicate/reference devices. The device has the same intended use and different technological characteristics but is substantially equivalent.

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Clinical Study (PNS Threshold): 33 individuals. The document does not specify the country of origin or whether it was retrospective or prospective, but clinical studies for such thresholds are typically prospective.
- Nonclinical Tests (Image Quality, Software V&V, Performance Tests): The document does not specify a numerical sample size but mentions "sample clinical images were taken" for new coils and software features. It does not provide provenance (country, retrospective/prospective) for these samples specifically, but they would likely be internal studies.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not explicitly state the number or qualifications of experts used to establish ground truth for the image quality assessments, software V&V, or performance tests. However, it indicates that the interpretation of images and spectra is done "by a trained physician." For image quality assessments, it's implied that Siemens' internal experts or qualified personnel performed these.
Adjudication Method for the Test Set:
- The document does not specify an adjudication method like 2+1 or 3+1 for any of the tests described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned for the entire device. The submission focuses on demonstrating substantial equivalence through compliance with standards, verification, and validation, rather than a direct comparison of reader performance with and without the new AI features (if any specific AI features are implied, they are integrated within the "new software" and not evaluated separately as AI-assisted reading).
- There is no mention of an effect size for human readers with vs. without AI assistance.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No standalone performance study of an algorithm is explicitly described. The device is an MRI system, which always involves a human operator and physician interpretation. The "new software" features are part of the overall system performance, not presented as a discrete AI algorithm for standalone evaluation.
Type of Ground Truth Used:
- PNS Threshold Study: The ground truth would be the observed physiological response (nerve stimulation) in the 33 individuals, used to set the safety threshold.
- Image Quality Assessments: The ground truth would likely be internal Siemens expert assessment of expected image characteristics, clarity, and diagnostic interpretability against established quality metrics or comparisons to images from the predicate device.
- Software V&V/Performance Tests: Ground truth would be derived from specifications, expected functional outputs, and adherence to regulatory standards.
- General Diagnosis: The "Indications for Use" state that images and spectra, "when interpreted by a trained physician yield information that may assist in diagnosis." This implies physician interpretation is the ultimate ground truth for diagnostic purposes in clinical use, but not for the technical performance studies described in the 510(k).
Sample Size for the Training Set:
- The document does not provide information on a specific training set size. This type of 510(k) submission generally does not detail the internal development and training data for software components, especially when the changes are primarily updates to an existing system, rather than a de novo AI algorithm approval.
How the Ground Truth for the Training Set Was Established:
- Since no specific training set or study for algorithm training is described, the method for establishing its ground truth is not provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2017

SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL FIELDS, ESQ. REGULATORY TECHNICAL SPECIALIST 65 VALLEY STREAM PARKWAY, MAILCODE 65-1A MALVERN, PA 19355

Re: K170396

Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: May 17, 2017 Received: May 19, 2017

Dear Cordell Fields, Esq:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

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

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Indications for Use Section 4 Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170396

Device Name

MAGNETOM Vida

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
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FORM FDA 3881 (8/14)

PSC Publishing Services (301) 443-674) 4 EF

Siemens 510(k) Traditional Premarket Notification

Siemens MR System MAGNETOM Vida (3T) with syngo MR XA10A Software

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Section 5 510(k) Summary

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.

l. General Information

Establishment	Siemens Medical Solutions USA, Inc.40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration Number: 2240869
Date Prepared	February 08, 2017
Manufacturer	Siemens Healthcare GmbHHenkestrasse 127Erlangen, Bayern, Germany 91052Registration Number: 3002808157
Contact Person	Cordell L. Fields, EsqRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.
Device Name	MAGNETOM Vida
Trade Name	MAGNETOM Vida

Classification Name:	Magnetic Resonance Diagnostic Device (MRDD
Classification Panel:	Radiology
CFR Code:	21 CFR § 892.1000
Classification:	Class II
Product Code:	Primary: LNH, Secondary: LNI, MOS

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:

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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:
- magnet
- gradient coil |
- patient table (fixed and mobile)
new coils:
- Body Coil -
- BioMatrix Head/Neck 20 TCS -
- BioMatrix Head/Neck 64 CS -
- BioMatrix Spine 72 RS -
- BioMatrix Spine 32 RS -
- UltraFlex Large 18 -
- UltraFlex Small 18 -
- Shoulder Shape 16 -
- -Tx/Rx Knee 18
other components such as: ।
- helium compressor
- cover incl. new touch displays with extended functionalty and redesigned control island
- computers and monitor

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respiratory sensor (respiratory sensor loops integrated into BioMatrix Spine 32 RS and BioMatrix Spine 72 RS)
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

| SliceAdjust (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 covering the regions chest, abdomen, pelvis and also extensions towards head and legs.)
। CoilShim (reduce patient induced strongly localized B0 inhomogeneities by generating the respective anatomy-specific B0 field with local shim coil elements integrated in the local Rx coils BioMatrix Head/Neck 20 TCS and BioMatrix Head/Neck 64 CS.)
Left/Right Balancing (method for balancing the signal in the left and right brain hemispheres to reduce the signal asymmetry between the left and right brain hemispheres.)

New Software / Platform

Software platform (new software version syngo MR XA10A based on the | new 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 (left-hand side (LHS) and right-hand side (RHS) concept । with dual monitor workflow where patient handling and scanning is separated from post-processing and data handling. The "LHS" contains scan-related elements such as the Patient Browser (Scheduler) and scan UI and displays the inline processed images. On the "RHS" additional results are 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)

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SIEMENS

। 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 echos 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 on the RHS)
Multiframe DICOM format (now available in addition with improvements in performance, application support, navigation and data interchange.)
Touch positioning (Select&GO) (to position the patient to the isocenter by using the touch displays integrated in the system cover)

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 k-space under-sampling. Compressed Sensing Cardiac Cine can be performed in single-shot and in multi-shot mode.
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 qoal to correct MRI images for local coil sensitivity variations and to generate homogenous MRI images. Three different matrix sizes are available now.
। iPAT: 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 sequence 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 non-selective inversion recovery imaging.

Modified (general) Software / Platform

Patient Browser (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.

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SIEMENS

MR View&GO: For quality assurance, image viewing, basic post- । processing, printing and result distribution. The functionality is provided in workflow steps which provide guidance, allow independent work and do not require any reloading of data.
। Prior Handling: for the display of available priors.
System Start and Shutdown: improvements with a System Start Timer and | shutdown unattended by the user.

Other Modifications and / or Minor Changes

SAR: software for the simulation of local SAR.
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.
Siemens "Healthineers": new Siemens brand.
Improved Adiustments: transmitter adjustment to avoid any signal- | manipulating dephasing, 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. l
BEAT IRTT: 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.

Technological Characteristics

MAGNETOM Vida with software syngo MR XA10A has different technological characteristics as the predicate device MAGNETOM Skyra (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 Vida conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

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

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SIEMENS

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.
lmage quality assessments of all new/modified pulse sequence types and l 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 33 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

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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 Vida with software syngo MR XA10A 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.

RecognitionNumber	ProductArea	Title of Standard	Reference Numberand 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
19-1	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirements andtests	60601-1-2 Edition3:2007-03	IEC
12-271	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basic safetyand essential performance ofmagnetic resonance equipmentfor medical diagnosis	60601-2-33 Ed.3.1:2013	IEC
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971 Secondedition 2007-10	ISO
5-96	General	Medical devices - Application ofusability engineering to medicaldevices	62366 Edition 1.02015	AAMIANSIIEC
13-32	Software	Medical device software -Software life cycle processes	62304:2006	AAMIANSIIEC
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 03/16/2012	PS 3.1 - 3.20(2016)	NEMA
RecognitionNumber	ProductArea	Title of Standard	Reference Numberand date	StandardsDevelopmentOrganization
2-156	Biocompatibility	biological evaluation of medicaldevices -- part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility)	10993-1:2009/(R)2013	AAMIANSIISO

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Substantial Equivalence

MAGNETOM Vida with software syngo MR XA10A includes most of the features of the predicate device and additional new and modified hardware and software as noted above.

Predicate Device & Reference Device Information

Predicate Device	FDA ClearanceNumber and Date	Productcode	Manufacturer
syngo MR E11C for MAGNETOMSkyra	K153343,cleared April 15,2016	LNHLNI,MOS	Siemens AG /Siemens HealthcareGmbH
Reference Devices	FDA ClearanceNumber and Date	Productcode	Manufacturer
syngo MR E11C for MAGNETOMAera
Please note: Gradient Power AmplifierGPA 90/22/F (XQ gradient engine), aspart of MAGNETOM Aera with syngo MRE11C, is the reference device related toGradient Power Amplifier GPA 90/22/DG(XQ gradient engine)	K153343,cleared April 15,2016	LNHLNI,MOS	Siemens AG /Siemens HealthcareGmbH
syngo MR E11A for MAGNETOMSkyra	K141977,cleared November19, 2014	LNHLNI,MOS	Siemens AG
syngo MR E11C-AP02 forMAGNETOM Skyra	K163312,cleared January27, 2017	LNHLNI,MOS	Siemens HealthcareGmbH
syngo.via VB10APlease note: reference device related toNumaris/X	K150843,cleared April 24,2015	LLZ	Siemens AG
MAGNETOM AvantotmPlease note: reference device related tothe cover (manufacturing procedure andmaterial)	K162102,cleared November22, 2016	LNHLNI,MOS	Siemens AG /Siemens HealthcareGmbH
syngo MR D13C for MAGNETOMSkyra	K123510,cleared May17, 2013	LNH	Siemens AG

Siemens 510(k) Traditional Premarket Notification

February 08, 2017

Siemens MR System MAGNETOM Vida (3T) with syngo MR XA10A Software

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Predicate Device & Reference Device Information

syngo MR D13A for MAGNETOMVerio	K121434,cleared November5, 2012	LNHLNI,MOS	Siemens AG

Conclusion as to Substantial Equivalence

MAGNETOM Vida with software syngo MR XA10A has the same intended use and different technological characteristics as the predicate device system, MAGNETOM Skyra with synqo 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 Vida 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 Vida with software syngo MR XA10A does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Skyra with software syngo MR E11C (K153343 cleared on April 15, 2016).

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.