(140 days)
No
The document describes software updates and hardware modifications to an existing MR system. While it mentions image processing and post-processing, there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on software verification/validation and substantial equivalence to the predicate, without describing AI/ML-specific validation methods or metrics.
No
The device is described as a "magnetic resonance diagnostic device" used for producing images and information to assist in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images/spectra "may assist in diagnosis."
No
The device description explicitly states that the submission includes "new hardware components" and describes the device as a "MAGNETOM MR system," which is a hardware-based imaging device. While software is a key component, it is part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. This is a description of an in vivo diagnostic device, meaning it performs diagnosis on living patients.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue. The device described here does not process such samples.
- Device Description: The description focuses on the hardware and software of an MRI system, which is used for imaging the inside of a patient's body directly.
Therefore, the MAGNETOM MR system described is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Your MAGNETOM MR 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 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 MR 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
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Avanto and MAGNETOM Verio D with software syngo MR E11D, is a modification of the previously cleared predicate device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A (K121434). Software version syngo E11D for MAGNETOM Avanto and MAGNETOM Verio includes software applications migrated from the previously cleared MAGNETOM Aera and Skyra systems with syngo MR E11C (K153343). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:
Software
- Sequences or Algorithms:
- New sequences for both systems with syngo MR E11D with respect to syngo MR D13A :
- HISTO sequence (as part of the new application LiverLab)
- O Beat map
- DSI (Diffusion Spectrum Imaging)
- Improvements in BLADE Imaging (fast TSE) O
- New sequences for both systems with syngo MR E11D with respect to syngo MR D13A :
- Modified sequences for both systems with syngo MR E11D with respect to syngo MR D13A:
- syngo WARP-SEMAC (Advanced WARP)
- Fast DIXON (TSE DIXON)
- SPAIR fat sat improvements (applicable for 3T MR Systems addressed by syngo MR E11D)
- Improvements in Liver Segmentation
- Improvement in Multi Echo Dixon for Fat Iron Quantification
- A flow compensated SE sequence for 3T systems
- Improvements in Inline Ventricular function
- Improvements in VIBE (TWIST-VIBE)
- Minor modifications of sequences or algorithms for both systems with syngo MR E11D with respect to syngo MR D13A:
- EPI sequence: B1 control loop for a better DTI signal stability
- Improved Body DWI imaging using a Flash-based PAT reference scan
- Improved SPAIR fat saturation in haste acquisitions
- Improved ACC algorithm to reduce artifacts
- Improved spoiling for the TurboFLASH sequence, especially for MPRAGE protocols
- Improved FatSat option for MSK imaging
- B1-corrected abdominal T1 mapping
- ICEPAT algorithm change
- Improved Dixon sequence
- Prepulese functionality now available for Petra sequence
Applications:
- New applications for MAGNETOM Avanto //erio with syngo MR E11D with respect to syngo D13A:
- LiverLab
- MyoMaps
- TWIST VIBE (FREEZEit Body MRI)
- Advanced WARP (WARP-SEMAC)
- Dot Cockpit
- Dynamic Breast Evaluation and Auto Bolus Detection for Breast Dot Engine
- New Dot Engines for MAGNETOM Avanto /Verio with syngo MR E11D with respect to MAGNETOM Aera/Skyra with software syngo D13A:
- Spine Dot Engine
- Large Joint Dot Engine (knee, hip, shoulder)
- Breast Dot Engine
Minor modifications of applications for MAGNETOM Avanto /Verio with syngo MR E11D with respect to syngo D13A:
- Improvements in Abdomen Dot Engine and Tim CT Onco Dot Engine
- Improvement in Auto Coil Selection
- TimCT Onco Improvements
- Neuro DTI: Customized diffusion directions
- Minor modifications to support the usability of the Avanto /Verio with syngo MR E11D with respect to syngo D13A:
- Improvement based on stimulation monitoring
- AutoAlign Spine is integrated within Spine Dot Engine
- Support for Internet protocol v6 support
- Economic mode intended for energy saving
- Inclusion of:
- Local AIF within Neuro Perfusion
- syngo BreVis
- Ability to interface with syngo.via post-processing
- SEEit (Marketing bundle being made available for all subject device systems)
Hardware
- New HW-components for MAGNETOM Avanto /Verio:
- MaRS (Measurement and reconstruction system)
The MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D will be offered as in-field upgrades for the currently installed MAGNETOM Avanto and Verio systems.
Mentions image processing
Yes, The device produces images and states that imaging is used during interventional procedures. It also mentions "post-processing of magnetic resonance images."
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 / Interventional procedures, diagnostic setting
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 Performance Testing:
- 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 testing was completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016.
Key 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 Performance Testing:
No clinical tests were conducted to support the claim of substantial equivalence. Sample clinical images have been provided in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. Cordell Fields Regulatory Specialist 40 Liberty Blvd Mailcode 65-1A Malvern, Pennsylvania 19355
November 6, 2018
Re: K181613
Trade/Device Name: MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, AND MOS Dated: October 10, 2018 Received: October 11, 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
1
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.html; 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 (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 mediation-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.
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
2
Indications for Use
510(k) Number (if known) K181613
Device Name
MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D
Indications for Use (Describe)
Your MAGNETOM MR 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 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 MR 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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3
510(k) Summary
MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Date Prepared June 14, 2018
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen China Establishment Registration Number: 3004754211
Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Establishment Registration Number: 3002808157
2. Contact Information
Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA
4
Phone: (610) 448-6545 Fax: (610) 448-6469 E-mail: cordell.fields@siemens-healthineers.com
3. Device Name and Classification
| Trade Name | MAGNETOM Avanto and MAGNETOM Verio with software
syngo MR E11D |
|-----------------------|-------------------------------------------------------------------|
| 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 |
4. Legally Marketed Predicate Device
| Trade Name | MAGNETOM Avanto and MAGNETOM Verio with software |
|---|---|
| syngo MR D13A | |
| 510(k) Number | K121434, Cleared November 05, 2012 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH |
| Secondary: LNL MOS |
5. Device Description
The subject device, MAGNETOM Avanto and MAGNETOM Verio D with software syngo MR E11D, is a modification of the previously cleared predicate device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A (K121434). Software version syngo E11D for MAGNETOM Avanto and MAGNETOM Verio includes software applications migrated from the previously cleared MAGNETOM Aera and Skyra systems with syngo MR E11C (K153343). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:
Software
.
- Sequences or Algorithms:
- New sequences for both systems with syngo MR E11D with respect to syngo MR D13A :
- HISTO sequence (as part of the new application LiverLab) o
- O Beat map
- DSI (Diffusion Spectrum Imaging) o
- Improvements in BLADE Imaging (fast TSE) O
- New sequences for both systems with syngo MR E11D with respect to syngo MR D13A :
5
SIEMENS
- Modified sequences for both systems with syngo MR E11D with respect to syngo MR D13A:
- syngo WARP-SEMAC (Advanced WARP) O
- Fast DIXON (TSE DIXON) o
- SPAIR fat sat improvements (applicable for 3T MR Systems addressed by o syngo MR E11D)
- Improvements in Liver Segmentation O
- Improvement in Multi Echo Dixon for Fat Iron Quantification o
- O A flow compensated SE sequence for 3T systems
- Improvements in Inline Ventricular function O
- Improvements in VIBE (TWIST-VIBE) O
- Minor modifications of sequences or algorithms for both systems with syngo MR E11D with respect to syngo MR D13A:
- EPI sequence: B1 control loop for a better DTI signal stability O
- Improved Body DWI imaging using a Flash-based PAT reference scan O
- Improved SPAIR fat saturation in haste acquisitions O
- Improved ACC algorithm to reduce artifacts O
- Improved spoiling for the TurboFLASH sequence, especially for MPRAGE O protocols
- Improved FatSat option for MSK imaging o
- B1-corrected abdominal T1 mapping O
- ICEPAT algorithm change O
- O Improved Dixon sequence
- Prepulese functionality now available for Petra sequence O
Applications:
- New applications for MAGNETOM Avanto //erio with syngo MR E11D with respect to syngo D13A:
- o LiverLab
- MyoMaps O
- TWIST VIBE (FREEZEit Body MRI) O
- Advanced WARP (WARP-SEMAC) O
- Dot Cockpit O
- Dynamic Breast Evaluation and Auto Bolus Detection for Breast Dot O Engine
- New Dot Engines for MAGNETOM Avanto /Verio with syngo MR E11D with respect to MAGNETOM Aera/Skyra with software syngo D13A:
- Spine Dot Engine o
- Large Joint Dot Engine (knee, hip, shoulder) O
- Breast Dot Engine o
Minor modifications of applications for MAGNETOM Avanto /Verio with syngo MR E11D with respect to syngo D13A:
6
SIEM
- Improvements in Abdomen Dot Engine and Tim CT Onco Dot Engine O
- O Improvement in Auto Coil Selection
- TimCT Onco Improvements O
- o Neuro DTI: Customized diffusion directions
- Minor modifications to support the usability of the Avanto /Verio with syngo MR E11D with respect to syngo D13A:
- Improvement based on stimulation monitoring O
- AutoAlign Spine is integrated within Spine Dot Engine O
- Support for Internet protocol v6 support O
- O Economic mode intended for energy saving
- Inclusion of: O
- ഗ്ന Local AIF within Neuro Perfusion
- syngo BreVis
- Ability to interface with syngo.via post-processing O
- SEEit (Marketing bundle being made available for all subject device O systems)
Hardware
.
- New HW-components for MAGNETOM Avanto /Verio:
- MaRS (Measurement and reconstruction system)
The MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D will be offered as in-field upgrades for the currently installed MAGNETOM Avanto and Verio systems.
6. Indication for Use
The indications for use for the subject device is the same as the predicate device and is as follows:
Your MAGNETOM MR 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 MR 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.
7
7. Substantial Equivalence
The MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D is substantially equivalent to the following device:
| Predicate Device | FDA Clearance
Number | FDA Clearance
Date | Product Code |
|-------------------------------------------------------------------|-------------------------|-----------------------|------------------|
| MAGNETOM Avanto and MAGNETOM
Verio with software syngo MR D13A | K121434 | November 05, 2012 | LNH, LNI,
MOS |
As described above, the MAGNETOM Avanto Dot and MAGNETOM Verio Dot with software synqo MR E11D includes features already cleared on the following devices:
| Reference Device | FDA Clearance Number | FDA Clearance Date | Product Code |
|---|---|---|---|
| Software syngo MR E11C for the | |||
| MAGNETOM System Aera and | |||
| MAGNETOM System Skyra | K153343 | April 15, 2016 | LNH, LNI, |
| MOS |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The subject device MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D is substantially equivalent to the predicate device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A, with regard to the operational environment, programming language, operating system, and performance.
The subject device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D, conforms to the IEC 62304, Edition 1.1, 2015-06, standard for software medical devices 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 as that of the predicate device.
9. Nonclinical Performance Testing
The following performance testing was conducted on the subject device:
- 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 testing was completed in accordance with the FDA guidance । document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016
8
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.
MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D conforms to the following FDA recognized and international IEC and ISO standards:
| Recogniton
Number | Product
Area | Title of Standard | Reference
Number and
date | Standards
Development
Organization |
|----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) Medical
electrical equipment - Part 1:
General requirements for basic
safety and essential
performance (IEC 60601-
1:2005, MOD) | ES60601-
1:2005/(R)20
12 and
A1:2012, | AAMI ANSI |
| 19-1 | General II
(ES/EMC) | Medical electrical equipment -
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic compatibility -
Requirements and tests | 60601-1-2
Edition 3:
2007-03 | IEC |
| 12-271 | Radiology | Medical electrical equipment -
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis | 60601-2-33
Ed. 3.1:2013 | IEC |
| 5-40 | General I
(QS/RM) | Medical devices - Application
of risk management to medical
devices | 14971
Second
Edition 2007-
03-01 | ISO |
| 5-89 | General I
(QS/RM) | Medical electrical equipment -
Part 1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability | 60601-1-6
Edition 3.1
2013-10 | IEC |
| 13-32 | Software/
Informatics | Medical device software -
Software life cycle processes | IEC 62304
Edition 1.1
2015-06 | AAMI ANSI
IEC |
9
SIEMENS
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device. Sample clinical images have been provided in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
10. 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 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 device is intended for healthcare professionals familiar with and responsible for the acquisition and-post processing of magnetic resonance images.
11.Conclusion as to Substantial Equivalence
There are no changes to the indications for use for the subject device as compared to that of the legally marketed predicate device. MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A (K121434).
While the new and modified software and hardware features provide additional capabilities compared to the predicate device, the additional capabilities are currently cleared features of the reference devices MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11C (K153343) and do not raise new questions of safety and effectiveness. All features have been verified and validated to support the claim of substantial equivalence to the predicate device.
Siemens believes that the subject device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D, is substantially equivalent to the predicate device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A.