Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions "Deep Resolve Boost" and "Deep Resolve Sharp" and describes their training and validation using datasets, which are characteristic of AI/ML techniques, specifically deep learning.

Therapeutic

No
The device is a magnetic resonance diagnostic device used to produce images and spectra to assist in diagnosis, not to provide therapy.

Diagnostic

Yes
The text explicitly states that the MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD).

SaMD (Software as a Medical Device)

No

The device description explicitly states that the subject devices consist of "new and modified software and hardware".

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the MAGNETOM system is a magnetic resonance diagnostic device (MRDD). It produces images and spectra of the internal structure and/or function of the head, body, or extremities. This is a form of in vivo (within a living organism) diagnostic imaging.
IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The MAGNETOM system does not perform tests on such samples.
Input Modality: The input modality is Magnetic Resonance (MR), which is an imaging technique applied directly to the patient, not to a sample.

While the device is a diagnostic device and uses advanced technology including AI for image processing, its method of obtaining diagnostic information is through imaging the patient directly, not by analyzing samples in vitro.

PCCP (Predetermined Change Control Plan) Authorized

No
The input letter does not contain explicit language stating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

LNH, LNI, MOS

Device Description

The subject devices, MAGNETOM Aera (including MAGNETOM Aera Mobile), MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM PrismaTM, 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:

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)

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

Magnetic Resonance

Anatomical Site

head, body, or extremities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician, healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

Description of the training set, sample size, data source, and annotation protocol

Deep Resolve Boost:
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.
The acquired datasets 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 of noise and mirroring of k-space data.

Deep Resolve Sharp:
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.
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.

Description of the test set, sample size, data source, and annotation protocol

Deep Resolve Boost:
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.

Deep Resolve Sharp:
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), 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 reconstructions with and without Deep Resolve Sharp.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical Tests:
Software verification and validation: Tested new or modified software features. Source/Rationale: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Sample clinical images: Tested new or modified software features. Source/Rationale: Guidance for submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
Image quality assessment by sample clinical images: Tested new / modified pulse sequence types, comparison images between the new / modified features and the predicate device features.
Physio logging Verification Report: Tested Physio logging. Source/Rationale: New Feature Introduction.

Performance testing for coils:
Performance bench test: Tested SNR and image uniformity measurements for coils, Heating measurements for coils. Source/Rationale: Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.

AI Features/Applications training and validation:
Deep Resolve Boost and Deep Resolve Sharp: Performance evaluated by quality metrics (PSNR, SSIM, perceptual loss), visual comparisons, and in-house tests (visual rating, image sharpness by intensity profile comparisons).

Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K213693

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K221733, K220939

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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).