MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Q: Who is the manufacturer of MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560).

Q: What is the FDA product code for MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit?

510(k) clearance (submission type: Traditional).

Q: Does MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit use AI or machine learning?

Yes. MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit (K231560) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: Who can help prepare an FDA 510(k) submission like MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Q: Can an AI/ML device like MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K231560 · Siemens Medical Solutions USA, Inc. · LNH · Oct 23, 2023 · Radiology

Device Facts

Record ID	K231560
Device Name	MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	LNH · Radiology
Decision Date	Oct 23, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML

Intended Use

The 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. The 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 Story

MAGNETOM series (Vida, Lumina, Aera, Skyra, Prisma) are MRI systems using magnetic resonance to generate diagnostic images/spectra of head, body, and extremities. Systems utilize RF, gradient, and magnet hardware to acquire signals; syngo MR XA60A software processes data for reconstruction and display. Operated by trained physicians/technicians in clinical settings. New features include Deep Resolve Boost (HASTE, EPI Diffusion) and Deep Resolve Sharp for image enhancement/denoising, and MR Fingerprinting. Output assists clinicians in diagnosis and interventional guidance. Benefits include reduced scan times and improved image quality via deep learning reconstruction. Data input involves k-space acquisition; output is cross-sectional imagery. Interventional use requires MR-safe accessories.

Clinical Evidence

No clinical trials conducted. Evidence consists of bench testing, software verification/validation, and sample clinical images. Performance of AI features (Deep Resolve Boost/Sharp) characterized by PSNR, SSIM, and visual comparison to predicate. Literature references provided for Deep Resolve Boost EPI Diffusion and HASTE sequences to support clinical feasibility.

Technological Characteristics

MRI system with magnet, RF, and gradient subsystems. Software: syngo MR XA60A. Connectivity: DICOM. Standards: IEC 60601-1, IEC 60601-2-33, ISO 14971, IEC 62304, NEMA MS 6. Features deep learning-based reconstruction (Deep Resolve). Hardware includes host computers and coils (e.g., Flex Loop Large).

Indications for Use

Indicated for use as an MRDD to produce cross-sectional images, spectroscopic images, and spectra of the head, body, or extremities to assist in diagnosis. Applicable to patients requiring MRI, including interventional procedures using MR-compatible devices. No specific age or gender contraindications defined.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

MAGNETOM Vida (K213693)

Reference Devices

MAGNETOM Sola (K221733)
MAGNETOM Lumina (K220939)

Related Devices

K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise · Siemens Healthcare GmbH · Dec 19, 2025
K220939 — MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A · Siemens Medical Solutions USA, Inc. · Apr 29, 2022
K223343 — MAGNETOM Amira; MAGNETOM Sempra · Siemens Medical Solutions USA, Inc. · Mar 28, 2023
K213693 — MAGNETOM Vida with syngo MR XA50A · Siemens Medical Solutions USA, Inc. · Feb 25, 2022
K203443 — MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea · Siemens Medical Solutions USA, Inc. · Mar 31, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square. October 23, 2023 Siemens Medical Solutions USA, Inc. Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355 Re: K231560 Trade/Device Name: MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: September 22, 2023 Received: September 22, 2023 Dear Alina Goodman: 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 (the 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 available 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. {1}------------------------------------------------ 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, D.G.K. Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K231560 Device Name MAGNETOM Vida: MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit Indications for Use (Describe) The 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. The 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. #### *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." {4}------------------------------------------------ # 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 Boulevard Malvern, PA 19355, USA Registration Number: 2240869 | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | May 25, 2023 | | Manufacturer: | Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Registration Number: 3002808157 Siemens Shenzhen Magnetic Resonance LTD Siemens MRI Center Hi-Tech Industrial Park (middle) Gaoxin C. Ave., 2nd Shenzhen 518057 P.R. CHINA Registration Number: 3004754211 | #### 2. Contact Information Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1(317)371-8593 E-mail: alina.goodman@siemens-healthineers.com #### 3. Device Name and Classification | Device/ Trade name: | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, | |-----------------------|----------------------------------------------------| | | MAGNETOM Prismafit, MAGNETOM Vida, MAGNETOM Lumina | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH | {5}------------------------------------------------ #### Secondary: LNI, MOS #### 4. Legally Marketed Predicate and Reference Device | 4.1. Predicate Device | | |-----------------------|---------------------------------------------| | Trade name: | MAGNETOM Vida | | 510(k) Number: | K213693 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | | 4.2. Reference Device | | | Trade name: | MAGNETOM Sola | | 510(k) Number: | K221733 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | | Trade name: | MAGNETOM Lumina | | 510(k) Number: | K220939 | | Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) | | Classification Panel: | Radiology | | CFR Code: | 21 CFR § 892.1000 | | Classification: | II | | Product Code: | Primary: LNH Secondary: LNI, MOS | #### 4. Intended Use The indications for use for the subject devices are the same as the predicate device: The 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. The 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}------------------------------------------------ # 5. Device Description The subject devices, MAGNETOM Aera (including MAGNETOM Aera Mobile), MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma™, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693). A high-level summary of the new and modified hardware and software is provided below: ## For MAGNETOM Vida with syngo MR XA60: ## Hardware Modified Hardware: - > Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)), - > MaRS (Measurement and Reconstruction System). Software New Features and Applications: - -> GRE PC - → Physio logging - → Deep Resolve Boost HASTE - > Deep Resolve Boost EPI Diffusion - → Open Recon - → MR Fingerprinting (MRF)1 Modified Features and Applications: - → BEAT_nav (re-naming only). - > myExam Angio Advanced Assist (Test Bolus). - -> Beat Sensor (all sequences). # For MAGNETOM Lumina with syngo MR XA60: # Hardware Modified Hardware: → Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)), # Software New Features and Applications: - -> GRE PC - -> Deep Resolve Boost HASTE - > Deep Resolve Boost EPI Diffusion - → Open Recon Modified Features and Applications: - → BEAT nav (re-naming only) - → myExam Angio Advanced Assist (Test Bolus) - → Beat Sensor (all sequences) # For MAGNETOM Skyra with syngo MR XA60: # Hardware Modified Hardware: - > Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)) - > MaRS (measurement and reconstruction system) # Software New Features and Applications: 1 MR Fingerprinting (MRF) is cleared under K213805 {7}------------------------------------------------ - → GRE_PC - → Physio logging - → Open Recon - > MR Fingerprinting (MRF)1 Modified Features and Applications: - > BEAT_nav (re-naming only) # For MAGNETOM Prisma and MAGNETOM Prisma™ with syngo MR XA60: # Hardware Modified Hardware: - > Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)) - → MaRS (measurement and reconstruction system) # Software New Features and Applications: - -> GRE PC - → Physio logging - → Open Recon - > MR Fingerprinting (MRF)1 Modified Features and Applications: → BEAT_nav (re-naming only) #### For MAGNETOM Aera with syngo MR XA60: # Hardware New Hardware: -> Flex Loop Large coil Modified Hardware: → Host computers ((syngo MR Acquisition Workplace (MRAWP) and syngo MR Workplace (MRWP)) - > MaRS (measurement and reconstruction system) # Software New Features and Applications: - -> GRE PC - → Physio logging - → Open Recon Modified Features and Applications: - → BEAT_nav (re-naming only) # 6. Substantial Equivalence MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma™, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A is substantially equivalent to the following predicate device: | Predicate Device | FDA Clearance Number and Date | Product Code | Manufacturer | |-------------------------------------|---------------------------------------|-----------------|-------------------------| | MAGNETOM Vida with syngo MR XA50A | K213693, cleared on February 25, 2022 | LNH LNI, MOS | Siemens Healthcare GmbH | | Reference Device | FDA Clearance Number and Date | Product Code | Manufacturer | | MAGNETOM Lumina with syngo MR XA50A | K220939, cleared April 29, 2022 | LNH LNI, MOS | Siemens Healthcare GmbH | | MAGNETOM Sola with syngo MR XA51A | K221733, cleared September 14, 2022 | LNH LNI, MOS | Siemens Healthcare GmbH | {8}------------------------------------------------ ## 7. Technological Characteristics The subject devices, MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma®, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A, are substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance. The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards. There are some differences in technological characteristics between the subject device and predicate device, including new and modified hardware/software. Here is summary of differences: | Hardware | Subject Devices | Predicate Device | Reference Devices* | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------------------------------------------------| | | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prismafit, MAGNETOM Vida and MAGNETOM Lumina with software syngo MR XA60A | MAGNETOM Vida with syngo MR XA50A (K213693) | MAGNETOM Sola with syngo MR XA51A (K221733) MAGNETOM Lumina with syngo MR XA50A (K220939) | | Magnet System | Yes | Yes | Yes | | RF System | Yes | Yes | Yes | | Transmission technique | Yes | Yes | Yes | | Gradient System | Yes | Yes | Yes | | Patient Table | Yes | Yes | Yes | | Multi-Nuclear Option - Supported Nuclei | Yes | Yes | Yes | | Computer | Yes Modified | Yes | Yes | | Coils | Yes New Flex Loop Large coil for MAGNETOM Aera | Yes | Yes | | Other HW components | Yes Modified (Beat Sensor - for MAGNETOM Vida and MAGNETOM Lumina, Image calculation system - except for MAGNETOM Lumina) | Yes | Yes | Summary hardware comparison table for the subject and predicate/reference device Summary software comparison table for the subject and predicate devices | | Subject Device | Predicate Device | |-------------------------------|----------------------------------------------------------|---------------------------------------------------| | Software | MAGNETOM Vida with software syngo MR XA50A | MAGNETOM Vida with syngo MR XA31A (K203443) | | Sequences | | | | SE-based pulse sequence types | New feature as listed in the Device Description above | Yes | {9}------------------------------------------------ | GRE-based/Steady-State pulse sequence types | New or modified pulse sequences as listed in the Device Description above | Yes | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----| | EPI-based pulse sequence types | New features as listed in the Device Description above | Yes | | Spectroscopy pulse sequence types | Yes | Yes | | Feature and Applications | | | | Other features and applications such as: -Application Suites -myExam Assists -Other Imaging Applications | New and Modified features and applications as listed in the Device Description above | Yes | | User interface and user interaction | Yes | Yes | | Viewing and post-processing | Yes | Yes | | Workflow and software utilization | Yes | Yes | | Patient Management | Yes | Yes | | Scan Modes and Pulse Sequences | Yes | Yes | | Scanning | Yes | Yes | | Reconstruction | New feature as listed in the Device Description above | Yes | | Image Display | Yes | Yes | | File/Data Management | Yes | Yes | The differences have been tested and the conclusion from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device. *The reference devices within this submission are used to demonstration previously cleared features which have been migrated to this submission with or without modification, a summary of these features are below; Flex Loop Large coil previsouly cleared under MAGNETOM Sola with syngo MR XA51A (K221733) Modified beat sensor, within hardware components, previsouly cleared under MAGNETOM Sola with syngo MR XA51A (K221733) Open Recon feature previously cleared under MAGNETOM Sola with syngo MR XA51A (K221733) myExam Angio Assist features previously cleared under MAGNETOM Sola with syngo MR XA51A (K221733) as MyExam Angio Advance Assist (Test Bolus) and MAGNETOM Lumina with syngo MR XA50A (K220939) as myExam Angio Assist (Care Bolus).. {10}------------------------------------------------ ## 8. Nonclinical Tests | Performance Test | Tested Hardware or Software | Source/Rationale for test | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Software verification and validation | New or modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | | Sample clinical images | New or modified software features | Guidance for submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices | | Image quality assessment by sample clinical images | - new / modified pulse sequence types. - comparison images between the new / modified features and the predicate device features | | | Physio logging Verification Report | Physio logging | New Feature Introduction | The following performance testing was conducted on the subject devices: The following performance testing for local coils was conducted on the predicate and the reference devices and can be reused for the subject devices: | Performance Test | Tested Hardware or Software | Source/Rationale for test | |------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Performance bench test | - SNR and image uniformity measurements for coils - Heating measurements for coils | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices | ## AI Features/Applications training and validation: The information below shows an executive summary of training and validation dataset of the Al features: | | Deep Resolve Boost: | Deep Resolve Sharp: | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Training and Validation data | TSE: more than 25,000 slices HASTE: pre-trained on the TSE dataset and refined with more than 10,000 HASTE slices EPI Diffusion: more than 1,000,000 slices The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. | on more than 10,000 high resolution 2D images. The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. | | Test Statistics and Test Results Summary | The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM). Most importantly, the performance was evaluated by visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels. | The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss. In addition, the feature has been verified and validated by inhouse tests. These tests include visual rating and an evaluation of image sharpness by intensity profile comparisons of | {11}------------------------------------------------ | | | reconstructions with and without Deep Resolve Sharp. | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Equipment | 1.5T and 3T MRI systems | | | Clinical Subgroups | No clinical subgroups have been defined for the collected dataset. | | | Demographic Distribution | Due to reasons of data privacy, we did not record gender, age and ethnicity during data collection. | | | Reference Standard | The acquired datasets (as described above) represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further under- sampling of the data by discarding k-space lines, lowering of the SNR level by addition Restricted of noise and mirroring of k-space data. | The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation. | The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared. # 9. Clinical Tests / Publications No clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided. Furthermore, additional clinical publications were referenced to provide information on the use of the following features and functions: | Feature | Publications | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Deep Resolve Boost EPI Diffusion | [1] Bae SH et al., Clinical feasibility of accelerated diffusion weighted imaging of the abdomen with deep learning reconstruction: Comparison with conventional diffusion weighted imaging, Eur J Radiol., 154 (2022) [2] Lee EJ et al., Feasibility of deep learning k-space-to-image reconstruction for diffusion weighted imaging in patients with breast cancers: Focus on image quality and reduced scan time, Eur J Radiol., 157 (2022) [3] Afat S et al., Acquisition time reduction of diffusion- weighted liver imaging using deep learning image reconstruction. Diagn Interv Imaging, (2022). [4] Benkert T et al., Improved Clinical Diffusion Weighted Imaging by Combining Deep Learning Reconstruction, Partial Fourier, and Super Resolution, ISMRM (2022) [5] Kim et al., Deep Learning-Accelerated Liver Diffusion- Weighted Imaging - Intraindividual Comparison and Additional Phantom Study of Free-Breathing and Respiratory- Triggering Acquisitions, Invest Radiol (2023) | {12}------------------------------------------------ | Deep Resolve Boost HASTE | [1] Herrmann J et al., Diagnostic Confidence and Feasibility of a Deep Learning Accelerated HASTE Sequence of the Abdomen in a Single Breath-Hold, Investigative Radiology, Volume 56, Number 5, May 2021. | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | [2] Shanbhogue K et al. Accelerated single-shot T2- weighted fat-suppressed (FS) MRI of the liver with deep learning-based image reconstruction: qualitative and quantitative comparison of image quality with conventional T2-weighted FS sequence. Eur Radiol. 2021 May 7. | | | [3] Herrmann J et al., Development and Evaluation of Deep Learning-Accelerated Single-Breath-Hold Abdominal HASTE at 3 T Using Variable Refocusing Flip Angles. Invest Radiol. 2021 Apr 22. | | | [4] Han S et al., Evaluation of HASTE T2 weighted image with reduced echo time for detecting focal liver lesions in patients at risk of developing hepatocellular carcinoma. Eur J Radiol. 2022 Nov 1;157:110588. | | | [5] Mule S et al., Fast T2-weighted liver MRI: Image quality and solid focal lesions conspicuity using a deep learning accelerated single breath-hold HASTE fat- suppressed sequence. Diagn Interv Imaging. 2022 Oct;103(10):479-485. | | | [6] Ginocchio LA et al., Accelerated T2-weighted MRI of the liver at 3 T using a single-shot technique with deep learning-based image reconstruction: impact on the image quality and lesion detection. Abdom Radiol (NY). 2022 Sep 28. | | | [7] Herrmann J et al., Comprehensive clinical evaluation of a deep learning-accelerated, single-breath-hold abdominal HASTE at 1.5 T and 3 T. Acad Radiol. 2022 Apr 22:S1076- 6332(22)00195-7. | | | [8] Ichinohe F. et al., Usefulness of Breath-Hold Fat- Suppressed T2-Weighted Images With Deep Learning-Based Reconstruction of the Liver, Invest Radiol., 2022 | | GRE_PC | [1] Guenthner C. et al. Ristretto MRE: A generalized multi- shot GRE-MRE sequence. NMR Biomed 2019; 32:e4049. | #### 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 a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens Healthcare GmbH adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images. MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma®*, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A conforms to the following FDA recognized and international IEC, ISO and NEMA standards: {13}------------------------------------------------ | Recognitio n Number | Product Area | Title of Standard | Reference Number and date | Standards Development Organization | |------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------| | 19-4 | General | Medical electrical equipment - part 1: general requirements for basic safety and essential performance | ES60601- 1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 | AAMI / ANSI | | 19-8 | General | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 60601-1-2 Edition 4.0:2014-02 | IEC | | 12-295 | Radiology | 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. 3.2 b:2015 | IEC | | 5-125 | General | Medical devices - Application of risk management to medical devices | 14971 Third Edition 2019-12 | ISO | | 5-114 | General I (QS/ RM) | Medical devices - Part 1: Application of usability engineering to medical devices | 62366-1:2015 | ANSI AAMI IEC | | 13-79 | Software/ Informatics | Medical device software - Software life cycle processes | 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | IEC | | 12-195 | Radiology | NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single- Channel Non-Volume Coils in Diagnostic MR Imaging | MS 6-2008 (R2014) | NEMA | | 12-342 | Radiology | Digital Imaging and Communications in Medicine (DICOM) Set | PS 3.1 - 3.20 (2021e) | NEMA | | 2-258 | Biocompati bility | Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. (Biocompatibility) | 10993-1 Fifth edition 2018-08 | AAMI ANSI ISO | # 11. Conclusion as to Substantial Equivalence MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma®, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA50A, 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 {14}------------------------------------------------ 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 Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma™, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA50A (K213693, cleared on February 25, 2022).