The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating and evaluating MR cardiac images.

syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

Device Description

The syngo.MR post-processing applications are synqo based post-processing software/applications to be used for viewing and evaluating' MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.

With SMRVB20 there are some new features, improvements and changes within the syngo.MR post-processing applications.

Within syngo.MR General VB20 there are the following new features and improvements:

Arithmetic tools (new): Addition, Division, Multiplication
Motion Correction (Elastic) (new): A Motion Correction algorithm can ● be used to perform elastic motion correction for angiography series (pre/post) or within 4D Breast datasets.
MR Combine feature (new): Composing is also available for axial series. ●
MR Prostate workflow provides PI-RADS™ v2 reporting (improved) ●
Harmonized MR Basic workflow (improved): Several basic workflows . for routine reading are consolidated in one MR Basic workflow.
. MR Neurology workflow: The MR Neurology workflow merges the already cleared workflows of MR Head, MR Neuro Perfusion, and MR Neuro Dynamics.
Easy Reading Layout in all workflows (improved): All workflows now include a viewing step with Easy Reading Layout.
Improved result management (improved): Multiple export options for . findings in the interactive Findings details dialog

Within syngo.MR Cardiology VB20 there are the following new features and improvements:

Volume Quantification Tool (new): Volume Quant provides the . capability to evaluate lesion volumes in the myocardium.
. Improved Result Distribution (improvement): Segmentation images can be exported as a result series.

Within syngo.MR Neurology VB20 there are the following new features, changes and improvements:

MR Neuro 3D workflow:
- Offline BOLD (new): offers the capability to run the GLM ● evaluations on raw BOLD data to generate fMRI statistical maps.
- . Offline DTI (new): offers the capability to generate TENSOR data together with all other diffusion maps (including b0. ADC. TraceW, FA, AD, RD) from raw diffusion series.
- DTI evaluation (new): offers quantitative evaluation of diffusion . parameters (FA, RD, AD, ADC, ...) using ROI, VOI, or voxels.
. Neuro-specific Mean Curve Tool (minor improvement): The application svngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neurospecific Mean Curve Tool), but no longer as a single application.

The syngo.MR Neuro Perfusion Engine Pro, described in K151353 (and cleared August 07, 2015), is therefore obsolete within SMRVB20, as all applications are already part of syngo.MR Neuro Perfusion Engine.

AI/ML Overview

This document describes the safety and effectiveness information supporting the Siemens syngo.MR post-processing applications (syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology), in the context of a 510(k) premarket notification (K163294). The focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than a standalone clinical study to establish new acceptance criteria. Therefore, several of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study, effect size) are not explicitly described in the provided text because a formal clinical study to prove new performance claims was not performed and not required for a substantial equivalence claim.

The submission focuses on new features and improvements to existing functionalities and does not define new "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, AUC) that a new device would need to meet. Instead, acceptance is based on demonstrating that the new features do not raise new questions of safety or effectiveness and that the device as a whole maintains substantial equivalence to its predicate devices, which are already legally marketed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for an updated software version rather than a de novo device, specific granular acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) are not defined in the document. The "acceptance criteria" are implicitly met by demonstrating that the new features conform to established safety and performance standards, and that the device's intended use and technological characteristics remain substantially equivalent to its predicate devices.

Acceptance Criteria (Implicitly based on Substantial Equivalence):

Device functions as intended for viewing, manipulating, and evaluating MR images.
New features do not introduce new questions of safety or effectiveness.
Device adheres to relevant industry standards (ISO 14971, IEC 62366-1, IEC 62304, NEMA DICOM).
Device maintains the same intended use as predicate devices.

Reported Device Performance (Implicit from Features and Conformity):

Feature/Area	Reported Status/Performance (Implicit)
syngo.MR General (new/improved features)
Arithmetic tools	New functionality for Addition, Division, Multiplication. Expected to be accurate for image manipulation.
Motion Correction (Elastic)	New capability for elastic motion correction in angiography and 4D Breast datasets. Expected to provide effective motion correction.
MR Combine feature (Composing for axial series)	New functionality. Expected to integrate axial series effectively.
MR Prostate workflow (PI-RADS™ v2 reporting)	Improved. Expected to facilitate standardized prostate MRI reporting.
Harmonized MR Basic workflow	Improved consolidated basic workflows for routine reading. Expected to streamline workflow.
MR Neurology workflow	Merges existing cleared workflows (MR Head, MR Neuro Perfusion, MR Neuro Dynamics). Expected to provide a unified, comprehensive neurological workflow.
Easy Reading Layout	Improved across all workflows. Expected to enhance user experience.
Improved result management	Multiple export options for findings. Expected to improve data handling and sharing.
syngo.MR Cardiology (new/improved features)
Volume Quantification Tool	New tool for evaluating lesion volumes in the myocardium. Expected to provide accurate volumetric measurements.
Improved Result Distribution	Segmentation images can be exported as result series. Expected to improve data utility.
syngo.MR Neurology (new/improved features)
Offline BOLD	New capability to run GLM evaluations on raw BOLD data for fMRI statistical maps. Expected to generate robust functional MR maps.
Offline DTI	New capability to generate TENSOR data and other diffusion maps from raw diffusion series. Expected to provide comprehensive DTI analysis.
DTI evaluation	New quantitative evaluation of diffusion parameters (FA, RD, AD, ADC, etc.) using ROI/VOI/voxels. Expected to provide accurate quantitative DTI metrics.
Neuro-specific Mean Curve Tool	Minor improvement, integrated into syngo.MR Neuro Perfusion. Expected to maintain functionality for mean curve analysis.
General Safety and Effectiveness	Labeling contains instructions, cautions, and warnings for safe use. Risk Management complies with ISO 14971:2007. Adherence to recognized industry standards (AAMI ANSI IEC 62366-1, ISO 14971, AAMI ANSI IEC 62304, NEMA DICOM PS 3.1-3.20). Operators are healthcare professionals. Device is substantially equivalent to predicate devices (K130749, K151353, K153343, K150843).

2. Sample size used for the test set and the data provenance

The document does not describe specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study. The evaluation focused on non-clinical data (software verification and validation, risk management, adherence to standards) to support the substantial equivalence claim for the updated software.

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

Not applicable, as no formal clinical test set requiring expert-established ground truth for performance metrics is described in this submission. The validation relies on demonstrating technical performance and equivalence to cleared predicate devices.

4. Adjudication method for the test set

Not applicable, as no formal clinical test set with an adjudication process is described in this submission.

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

Not applicable. This submission is for an update to a post-processing software that provides tools for clinicians, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to show human reader improvement. The document does not describe AI components or MRMC studies.

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

The document does not explicitly describe a standalone performance study for the algorithms. The "device" itself is software for viewing, manipulating, and evaluating MR images, serving as a tool for clinicians. The focus is on the software's ability to provide these functions accurately and safely as an aid to a human reader, implying a human-in-the-loop interaction for diagnostic purposes.

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

Not explicitly described in terms of a clinical ground truth for a performance study. The validation relies on technical verification and validation, ensuring the software performs its intended functions correctly and reliably, and that its outputs (e.g., measurements, processed images) are accurate based on engineering specifications and comparison against predicate device capabilities.

8. The sample size for the training set

Not applicable. This document describes an update to post-processing software, not a machine learning or AI model that would typically require a training set. The new features mentioned (e.g., arithmetic tools, motion correction, DTI evaluation) are standard image processing and analysis algorithms rather than models requiring large training datasets.

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

Not applicable, as no training set for a machine learning model is mentioned.

Summary of Approach:

This 510(k) submission for the syngo.MR post-processing applications focuses on demonstrating substantial equivalence to predicate devices for an updated software version. The "study" proving the device meets its (implicit) acceptance criteria relies on:

Detailed descriptions of new features and improvements.
Verification and validation activities to ensure these features function as intended and do not introduce new safety or effectiveness concerns.
Adherence to recognized industry standards (ISO 14971 for risk management, IEC 62366-1 for usability, IEC 62304 for software life cycle, NEMA DICOM for imaging communication).
A comparison of intended use and technological characteristics with legally marketed predicate devices (K130749, K151353, K153343, K150843) to affirm that the fundamental equivalence remains.

The absence of specific clinical performance study details (e.g., test set sizes, expert reviews, MRMC studies) is consistent with a 510(k) pathway for software updates that are considered substantially equivalent to existing devices and do not introduce entirely new diagnostic capabilities requiring extensive clinical validation.

Summary

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

February 6, 2017

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

Re: K163294

Trade/Device Name: syngo.MR General: syngo.MR Cardiology: syngo.MR Neurology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 21, 2016 Received: November 22, 2016

Dear Mr. 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. 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.

Sincerelv vours.

Michael D'Hara

For

Robert 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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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)

K163294

Device Name

syngo.MR General; syngo.MR Cardiology; syngo.MR Neurology

Indications for Use (Describe)

syngo.MR General is a syngo based post-processing software for viewing, manipulating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating MR cardiac images.

syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating MR neurological images.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

Traditional 510(k) Premarket Notification for: syngo.MR Post-Processing Applications Software VB20

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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.

Date of Summary Preparation: November 16, 2016

I. General Information

Importer / Distributor:	Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USA
Registration Number:	2240869
Manufacturer:	Siemens Healthcare GmbHHenkestr. 127D-91052 Erlangen, Germany
Registration Number:	3002808157
Contact Person:	Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.65 Valley Stream PkwyMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 448-6469Fax: (610) 427-3465Email: cordell.fields@siemens.com

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Device Name and Classification

Data	Details
Trade name /DeviceProprietaryName:	syngo.MR Generalsyngo.MR General contains several MR Radiologyworkflows and MR specific Evaluation features.It covers single and engine applications:syngo.MR Readingsyngo.MR General Routinesyngo.MR Cardiac Readersyngo.MR Composingsyngo.MR General Enginesyngo.MR General Engine is the precondition for all other,advanced MR post-processing applications and Engines.
	syngo.MR Cardiologysyngo.MR Cardiology covers single and engineapplications:syngo.MR Cardiac 4D Ventricular Functionsyngo.MR Cardiac Flowsyngo.MR Cardio Engine
	syngo.MR Neurologysyngo.MR Neurology covers single and engineapplications:syngo.MR Neuro Perfusionsyngo.MR Neuro Perfusion Mismatchsyngo.MR Neuro fMRIsyngo.MR Tractographysyngo.MR Neuro Perfusion Enginesyngo.MR Neuro 3D Engine
ClassificationName:	Regulation Description:Picture Archiving and Communication System (PACS)
ClassificationPanel:	Radiology
DeviceClassification:	Class II devices
Regulationnumber:	21 CFR § 892.2050

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Data	Details
Product Code:	Primary: LLZ, Secondary: LNH

Data	Details
Trade name /DeviceProprietaryName:	syngo.MR Generalsyngo.MR General contains several MR Radiologyworkflows and MR specific Evaluation features.It covers single and engine applications:• syngo.MR Reading• syngo.MR General Routine• syngo.MR Cardiac Reader• syngo.MR Composing• syngo.MR General Enginesyngo.MR General Engine is the precondition for allother, advanced MR post-processing applications andEngines.
Trade name /DeviceProprietaryName	syngo.MR Cardiologysyngo.MR Cardiology covers single and engineapplications:• syngo.MR Cardiac 4D Ventricular Function• syngo.MR Cardiac Flow• syngo.MR Cardio Engine
Trade name /DeviceProprietaryName	syngo.MR Neurologysyngo.MR Neurology covers single and engineapplications:• syngo.MR Neuro Perfusion• syngo.MR Neuro Perfusion Mismatch• syngo.MR Neuro fMRI• syngo.MR Tractography• syngo.MR Neuro Perfusion Engine• syngo.MR Neuro 3D Engine

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The software comprising the syngo.MR post-processing applications is postprocessing software/applications to be used for viewing and evaluating the

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designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating and evaluating MR cardiac images.

syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.

Device Description

With SMRVB20 there are some new features, improvements and changes within the syngo.MR post-processing applications.

Within syngo.MR General VB20 there are the following new features and improvements:

Arithmetic tools (new): Addition, Division, Multiplication
Motion Correction (Elastic) (new): A Motion Correction algorithm can ● be used to perform elastic motion correction for angiography series (pre/post) or within 4D Breast datasets.
MR Combine feature (new): Composing is also available for axial series. ●
MR Prostate workflow provides PI-RADS™ v2 reporting (improved) ●
Harmonized MR Basic workflow (improved): Several basic workflows . for routine reading are consolidated in one MR Basic workflow.
. MR Neurology workflow: The MR Neurology workflow merges the already cleared workflows of MR Head, MR Neuro Perfusion, and MR Neuro Dynamics.
Easy Reading Layout in all workflows (improved): All workflows now include a viewing step with Easy Reading Layout.
Improved result management (improved): Multiple export options for . findings in the interactive Findings details dialog

1 While viewing (i.e. assessing) of images from other vendors is always possible; for advanced post-processing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can´t be guaranteed for other vendors.

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Within syngo.MR Cardiology VB20 there are the following new features and improvements:

Volume Quantification Tool (new): Volume Quant provides the . capability to evaluate lesion volumes in the myocardium.
. Improved Result Distribution (improvement): Segmentation images can be exported as a result series.

Within syngo.MR Neurology VB20 there are the following new features, changes and improvements:

MR Neuro 3D workflow:
- Offline BOLD (new): offers the capability to run the GLM ● evaluations on raw BOLD data to generate fMRI statistical maps.
- . Offline DTI (new): offers the capability to generate TENSOR data together with all other diffusion maps (including b0. ADC. TraceW, FA, AD, RD) from raw diffusion series.
- DTI evaluation (new): offers quantitative evaluation of diffusion . parameters (FA, RD, AD, ADC, ...) using ROI, VOI, or voxels.
. Neuro-specific Mean Curve Tool (minor improvement): The application svngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neurospecific Mean Curve Tool), but no longer as a single application.

General Safety and Effectiveness Concerns

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 to potential hazards in a Risk Analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of MR images.

syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology conform to the applicable FDA recognized and international IEC, ISO and NEMA

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standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

Rec.- No.	Product Area	Title of Standard	Ref.- No. & Date	StandardsDevelopmentOrganization
5-96	General	Medical devices -Application of usabilityengineering to medicaldevices	62366-1:2015	AAMI ANSIIEC
5-40	General	Medical devices - application ofrisk management to medicaldevices	14971:2007	ISO
13-32	Software	Medical device software -Software life cycleprocesses	62304:2006	AAMI ANSIIEC
12-300	Radiology	Digital Imaging andCommunications inMedicine (DICOM) Set PS3.1-3.20 (2011)	PS 3.1 -3.20 (2016)	NEMA

The standards conformed to are the following:

Substantial Equivalence

Each of the medical devices, syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology, running with the herein described version SMRVB20 has the same Intended Use as the primary predicate device (see Table 1). The conclusions from the non-clinical data suggest that the additional features bear an equivalent safety and performance profile as that of the predicate device and also does not affect the Indications for use of it. Therefore syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology are considered to be substantially equivalent to their primary predicate devices, which are current legally marketed devices.

Table 1: Predicate devices for syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology

Primary Predicate Device	FDA Clearance	Product Code	for MedicalDevice syngo.x
syngo. MR Post-ProcessingSoftware(Version SMRVA16A)	K130749cleared August 20,2013	LLZ, LNH	MR GeneralMR Cardiology
syngo. MR Post-ProcessingSoftware VersionSMRVB10A	K151353cleared August 07,2015	LLZ, LNH	MR NeurologyMR General

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Secondary PredicateDevice	FDA Clearance	ProductCode	for MedicalDevice syngo.x
syngo MR E11C Software forSiemens MR Systems:MAGNETOM Aera (1.5T),MAGNETOM Skyra (3T) andMAGNETOMPrisma/Prismafit (3T)	K153343cleared April 15,2016	LNH, LNI,MOS	MR GeneralMR Neurology
syngo.via (VB10)	K150843cleared April 24,2015	LLZ	MR GeneralMR CardiologyMR Neurology

Conclusion as to Substantial Equivalence

The syngo.MR post-processing applications are intended for similar indications as cleared in their according primary predicate devices.

In summary, Siemens is of the opinion that the syngo.MR post-processing applications do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed primary predicate devices:

syngo.MR Post-Processing Software, version SMRVA16A (K130749 . cleared August 20, 2013) for syngo. MR General and syngo.MR Cardiology
syngo.MR Post-Processing Software, version SMRVB10A (K151353 . cleared August 07, 2015) for syngo.MR Neurology and syngo.MR General

There is new added functionality for the syngo.MR post-processing applications. The differences give the devices greater capabilities than the predicates, but the Intended Use, the basic technological characteristics and functionalities remain the same.

Therefore, Siemens believes that the subject device, the syngo.MR postprocessing applications syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology, are substantially equivalent to their primary predicate devices listed above in Table 1.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).