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 Vida with software syngo MR XA11A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA10A. A high level summary of the new and modified features is provided below:

Hardware
New Hardware

New coils:
BM Body 12 |
BM Spine 24 |
| Head/Neck 16
-Head 32 MR Coil 3T
Other components:
camera —
computer
Multi-Channel Interface —

Modified Hardware

Main components such as 32 independent RF channels -
-Other components such as Tx-Box / RF filter plate / transmit system

Software
New Features and Applications

GOKnee3D (examination comprising 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 with the iPAT mode CAIPIRINHA)
GOBrain (brain examination in short acquisition time)
GOBrain+ (adaptation of GOBrain pulse sequences)
| MR Breast Biopsy (supports planning and execution of MR guided breast biopsies and wire localizations)
| 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)

Modified Features and Applications

| SliceAdjust (the framework support was extended to include additional pulse sequence types)
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.)
iPAT / TSE Reference Scan (Changes in the TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)
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 masking performed on the prescan images used within the prescan/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)
Respiratory Sensor Support (additional support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)

Modified (general) Software / Platform

ー Single and dual monitor workflow (In the single monitor setup the features of the LHS monitor and RHS monitor are provided on separate tab-cards)
Touch positioning (Select&GO 2.0) (extension to additional body area positions when dedicated coils are plugged in)
Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)
MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions | instead of space) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension))

Other Modifications and / or Minor Changes

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 are taken from the patient registration)
GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)
Asymmetric saturation pulses (support for regional 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)
SPAIR FatSat (new "SPAIR Breast" mode in several pulse sequence types and extension of "Abdomen&Pelvis" and "Thorax" modes)
Compressed Sensing GRASP-VIBE (improvement of SPAIR fat saturation performance)
MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)
Siemens "BioMatrix" (extension with additional components)

AI/ML Overview

The provided text is a 510(k) Summary for the Siemens MAGNETOM Vida MRI system (K181433). It describes the device, its intended use, and compares it to a predicate device (MAGNETOM Vida with syngo MR XA10A). However, this document primarily focuses on establishing substantial equivalence based on non-clinical testing and adherence to standards, rather than clinical performance studies with acceptance criteria in the typical sense for AI/CADe devices.

Therefore, many of the requested details regarding acceptance criteria, clinical study design (sample size, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment (especially for AI/ML models) are not present in this document. This is because this submission is for an MRI system, not an AI/CADe device. It focuses on hardware and software modifications of a diagnostic imaging machine, not on an algorithm that interprets images.

Based on the provided text, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

The document discusses "performance testing" but does not provide specific quantitative acceptance criteria or detailed reported performance in a table format as might be expected for an AI/CADe device. Instead, the "acceptance" is qualitative:

Acceptance Criteria (Inferred from Text)	Reported Device Performance (Inferred from Text)
New coils perform as intended.	Sample clinical images were taken and deemed satisfactory.
New/modified software features and algorithms perform as intended.	Image quality assessments were completed. In some cases, comparison to predicate device features showed equivalent image quality.
Software development adheres to medical device software standards (IEC 62304:2006).	Software verification and validation testing was completed in accordance with FDA guidance.
System performance aligns with FDA guidance for Magnetic Resonance Diagnostic Devices.	Performance tests were completed in accordance with FDA guidance document.
Device safety and effectiveness are established through risk management (ISO 14971:2007) and adherence to other recognized standards (e.g., IEC 60601 series, NEMA).	Risks are controlled through hardware/software development, testing, and labeling. Compliance with listed standards is affirmed.
Device is substantially equivalent to the predicate.	"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."

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The document mentions "sample clinical images" were taken for the new coils and software features, but no specific number of patients or images is given.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: The device's output is "interpreted by a trained physician," implying that physicians are involved in assessing the images, but their specific role in establishing "ground truth" for the non-clinical tests is not detailed. For this type of MRI system submission, ground truth isn't established in the same way as for an AI interpretation algorithm. The "truth" is the physical output of the MRI system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This level of detail on ground truth adjudication is typically for AI/CADe clinical studies, not MRI system performance tests focused on image quality and safety.

5. 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 was done. The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device". This is not an AI-assisted reading device, but a diagnostic imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an MRI device, not an AI algorithm. "Performance tests" were done on the device itself and its components (e.g., image quality assessments).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For an MRI system, the "ground truth" for non-clinical testing refers to the physical and technical performance of the device (e.g., image clarity, signal-to-noise ratio, spatial resolution, adherence to safety limits). It is not about diagnostic accuracy against a clinical ground truth like pathology. The comparison is made against prior versions/predicate devices and established industry standards for image quality and safety.

8. The sample size for the training set:

Not applicable. This document does not describe an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no AI/ML training set is discussed.

In summary: The provided document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD), the MAGNETOM Vida MRI system. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device based on non-clinical performance testing (e.g., image quality assessments, software verification/validation) and conformity to recognized standards (e.g., IEC, ISO, NEMA). It explicitely states that no clinical tests were conducted for this submission. Therefore, the detailed requirements for AI/CADe device performance studies (like MRMC, training/test set ground truth, expert adjudication, etc.) are not addressed in this document because they are not relevant to this specific type of medical device submission.

Summary

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October 19, 2018

Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard Mail Code 65-1A MALVERN, PA 19355

Re: K181433

Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: September 26, 2018 Received: September 27, 2018

Dear Martin Rajchel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (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.

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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 (OS) 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 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,

Hol 2. nils

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

510(k) Number (if known)

K181433 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K181433

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
---------------	------------------------------------------------------------------------------------------------------------------------------------------

May 31, 2018 Date Prepared

Manufacturer Siemens Healthcare GmbH Henkestrasse 127 Erlangen, Bayern, Germany 91052 Registration Number: 3002808157

2. Contact Information

Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.raichel@siemens-healthineers.com

3. Device Name and Classification

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

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4. Legally Marketed Predicate Device

Trade Name:	MAGNETOM Vida
510(k) Number:	K170396, cleared June 14, 2017
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

5. Intended Use

The indications for use for the subject device 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 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

New Hardware

-New coils:
- BM Body 12 ।
- BM Spine 24 |
- | Head/Neck 16
- -Head 32 MR Coil 3T
Other components:
- camera —
- computer
- Multi-Channel Interface —

{5}------------------------------------------------

Modified Hardware

Main components such as 32 independent RF channels -
-Other components such as Tx-Box / RF filter plate / transmit system

Software

New Features and Applications

GOKnee3D (examination comprising 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 with the iPAT mode CAIPIRINHA)
GOBrain (brain examination in short acquisition time)
GOBrain+ (adaptation of GOBrain pulse sequences)
। MR Breast Biopsy (supports planning and execution of MR guided breast biopsies and wire localizations)
। 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)

Modified Features and Applications

। SliceAdjust (the framework support was extended to include additional pulse sequence types)
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.)
iPAT / TSE Reference Scan (Changes in the TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)
Care Bolus in Angio Dot Engine (workflow support for bolus administration (bolus detection))

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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 masking performed on the prescan images used within the prescan/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)
Respiratory Sensor Support (additional support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)

Modified (general) Software / Platform

ー Single and dual monitor workflow (In the single monitor setup the features of the LHS monitor and RHS monitor are provided on separate tab-cards)
Touch positioning (Select&GO 2.0) (extension to additional body area positions when dedicated coils are plugged in)
Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)
MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions । instead of space) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension))

Other Modifications and / or Minor Changes

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 are taken from the patient registration)
GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)
Asymmetric saturation pulses (support for regional 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)

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SPAIR FatSat (new "SPAIR Breast" mode in several pulse sequence types and extension of "Abdomen&Pelvis" and "Thorax" modes)
Compressed Sensing GRASP-VIBE (improvement of SPAIR fat saturation performance)
MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)
Siemens "BioMatrix" (extension with additional components)

7. Technological Characteristics

The subject device, MAGNETOM Vida with software syngo MR XA11A, is substantially equivalent to the predicate device with reqard to the operational environment, programming language, operating system, and performance.

MAGNETOM Vida with software syngo MR XA11A conforms to the standard for medical device software (IEC 62304:2006) and other relevant IEC and NEMA standards.

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

8. Nonclinical Tests

The following performance testing was conducted on the subject device:

Sample clinical images were taken for the new coils and new and modified software features.
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 device 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", dated May 11, 2005.
। Performance tests were completed in accordance with the FDA quidance 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.

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9. Clinical Tests

No clinical tests were conducted to support substantial equivalence for the subject device: however, sample clinical images were provided to support the new coils and new/modified hardware and software features per the FDA quidance document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016. Clinical publications were referenced to provide information on the use of some features and functions.

10. 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 ISO 14971:2007 compliance 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 risks. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

MAGNETOM Vida with software syngo MR XA11A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:

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
19-8	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests	60601-1-2 Edition4.0:2014-02	IEC

Siemens MR System MAGNETOM Vida (3T) with new syngo MR XA11A Software

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RecognitionNumber	ProductArea	Title of Standard	Reference Numberand date	StandardsDevelopmentOrganization
12-295	Radiology	Medical electrical equipment -Part 2-33: Particularrequirements for the basic safetyand essential performance ofmagnetic resonance equipmentfor medical diagnosis	60601-2-33 Ed.3.2:2015	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 03/16/2012Radiology	PS 3.1 - 3.20(2016)	NEMA
2-156	Biocompatibility	biological evaluation of medicaldevices - part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility)	10993-1:2009/(R)2013	AAMIANSIISO

11. Substantial Equivalence

MAGNETOM Vida with software syngo MR XA11A is substantially equivalent to the following predicate device:

Predicate Device	FDA ClearanceNumber and Date	Product code	Manufacturer
MAGNETOM Vida with syngo MRXA10A	K170396,cleared June 14, 2017	LNHLNI,MOS	Siemens HealthcareGmbH

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MAGNETOM Vida with syngo MR XA11A includes features already cleared on the following reference devices:

Reference Devices	FDA ClearanceNumber and Date	Product code	Manufacturer
MAGNETOM Skyra with syngoMR E11C-AP04	K173592,cleared February13, 2018	LNHLNI,MOS	Siemens HealthcareGmbH
MAGNETOM Skyra with syngoMR E11C	K153343,cleared April 15,2016	LNHLNI,MOS	Siemens AG /Siemens HealthcareGmbH
MAGNETOM Skyra with syngoMR E11C-AP02	K163312,cleared January27, 2017	LNHLNI,MOS	Siemens HealthcareGmbH
Compressed Sensing GRASP-VIBE for MAGNETOM Vida withsyngo MR XA10A	K173617,cleared March 30,2018	LNHLNI,MOS	Siemens HealthcareGmbH
syngo.via VB30Abased on syngo.via VB10A	syngo.via VB10A:K150843,cleared April 24,2015	LLZ	Siemens HealthcareGmbH

12. Conclusion as to Substantial Equivalence

MAGNETOM Vida with software syngo MR XA11A has the same intended use and same technological characteristics as the predicate device system, MAGNETOM Vida with syngo MR XA10A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical 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 Vida with software syngo MR XA11A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA10A (K170396, cleared on June 14, 2017).

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.