(445 days)
Unknown
The summary describes a new pulse sequence called MR Fingerprinting (MRF) which quantifies T1 and T2 relaxation times. While MRF is a novel technique for generating quantitative maps, the summary does not explicitly state whether AI/ML is used in the processing or analysis of the MRF data to derive these values or for any other function within the device. The description focuses on the acquisition method and performance testing, not the underlying algorithms used for quantification.
No
The device is indicated for use as a magnetic device for producing images and spectroscopic images that assist in diagnosis, and for imaging during interventional procedures, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images, spectra, and derived physical parameters "when interpreted by a trained physician, yield information that may assist in diagnosis." This directly indicates its role in the diagnostic process.
No
The device is described as a "MAGNETOM system," which is a magnetic resonance device (MRDD). While the submission focuses on software modifications (syngo MR XA31A and XA20A with the MR Fingerprinting pulse sequence), the device description explicitly states it is a system that produces images and spectra, indicating it includes hardware components necessary for MR imaging. The software is an integral part of this hardware system, not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the MAGNETOM system is a magnetic device (MRDD) that produces images and spectroscopic data of the internal structure and/or function of the head, body, or extremities. This is an in vivo imaging technique, meaning it examines the body directly, not specimens taken from the body.
- Intended Use: The intended use is to assist in diagnosis by providing images and derived parameters interpreted by a trained physician. This is consistent with an imaging device, not an IVD.
- Device Description: The device description focuses on the hardware and software for generating MR images and quantitative maps (T1 and T2 relaxation times) from the body.
- Performance Studies: The performance studies involve scanning phantoms and healthy volunteers, and clinical patient cases, all of which are in vivo applications.
The device is an MRI (Magnetic Resonance Imaging) system, which is a type of medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Your MAGNETOM system is indicated for use as a magnetic 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 system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Product codes
LNH, LNI, MOS
Device Description
The subject devices, MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with syngo MR XA20A, with the new pulse sequence MR Fingerprinting (MRF) consists of slightly modified software that are similar to what is currently offered in the predicate devices, MAGNETOM Vida with syngo MR XA31A (K203443) and MAGNETOM Vida with syngo MR XA20A (K192924) respectively.
The subject devices MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with synqo MR XA20A includes features that were cleared under K203443 and K192924 respectively. In addition to these features, the subject devices include a new pulse sequence type called MR Fingerprinting (MRF), a method that permits the simultaneous non-invasive quantification mapping of MRF-derived T1 and T2 relaxation times of brain tissue. The MRF is not intended to yield the ground truth T1 and T2 relaxation times of brain tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
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)
Performance Test: Sample clinical images
Tested Software: New feature "MR Fingerprinting" with the new 2D FISP MR-Fingerprinting pulse sequence type as part of the software version syngo MR XA20A and syngo MR XA31A*.
Source/Rationale: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices (November 2016)
Key Results: MRF T1 and T2 maps from volunteers were acquired to confirm the MRF sequence was executed successfully, and the resulting images were free of any obvious artifacts or degradations.
Performance Test: Performance bench test
Tested Software: Phantom and volunteer testing for quantitative evaluation of MRF-derived T1 and T2 values
Key Results: Repeated MRF T1 and T2 maps were acquired as part of a controlled study setup in phantom and healthy volunteers to evaluate the quantitative performance in terms of precision (repeatability and reproducibility).
Performance Test: Software verification and validation
Tested Software: New feature "MR Fingerprinting" with the new 2D FISP MR-Fingerprinting pulse sequence type as part of the software version syngo MR XA20A and syngo MR XA31A.
Source/Rationale: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)
Key Results: The process 'Software verification and validation' comprises systematic testing according to the MRF test specification. MRF T1 and T2 maps were retrieved using on a quantitative phantom to confirm that the results were stable and parametric values were reproducible across different systems within specified ranges.
Clinical Tests:
A study was performed with 3 healthy volunteers who were scanned multiple times using multiple systems to show the repeatability and reproducibility of the T1 and T2 maps acquired on the subject device and other MAGNETOM 3T scanners. In addition, several clinical patient cases were provided which demonstrated a longitudinal use case scenario, i.e., repeated scans from the same subject to observe changes over time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.
February 24, 2023
Siemens Medical Solutions USA, Inc. % Martin Rajchel Senior Regulatory Affairs Manager 40 Liberty Boulevard Mail Code 65-1A MALVERN PA 19355
Re: K213805
Trade/Device Name: MAGNETOM Vida Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH. LNI. MOS Dated: January 27, 2023 Received: January 27, 2023
Dear Martin Rajchel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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
2
Indications for Use
510(k) Number (if known)
K213805
Device Name MAGNETOM Vida
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic 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 system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: February 16, 2023
Manufacturer: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
2. Contact Information
Martin Rajchel Sr. Manager, Requlatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: 484-473-4209 E-mail: martin.rajchel@siemens-healthineers.com
3. Device Name and Classification
| Device name: | MAGNETOM Vida |
|---|---|
| Trade name: | MAGNETOM Vida |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
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SIEMENS Healthineers
4. Legally Marketed Predicate Devices
- i. Predicate for MAGNETOM Vida with software syngo XA31A and pulse sequence MR Fingerprinting
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K203443 |
| Clearance Date | March 31, 2021 |
| 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 |
- ii. Predicate for MAGNETOM Vida with software syngo XA20A and pulse sequence MR Fingerprinting
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K192924 |
| Clearance Date: | March 11, 2020 |
| 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 |
5. Intended Use
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
The subject devices, MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with syngo MR XA20A, with the new pulse sequence MR Fingerprinting (MRF) consists of slightly modified software that are similar to
5
SIEMENS Healthineers
510(k) Summary - K213805
what is currently offered in the predicate devices, MAGNETOM Vida with syngo MR XA31A (K203443) and MAGNETOM Vida with syngo MR XA20A (K192924) respectively.
The subject devices MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with synqo MR XA20A includes features that were cleared under K203443 and K192924 respectively. In addition to these features, the subject devices include a new pulse sequence type called MR Fingerprinting (MRF), a method that permits the simultaneous non-invasive quantification mapping of MRF-derived T1 and T2 relaxation times of brain tissue. The MRF is not intended to yield the ground truth T1 and T2 relaxation times of brain tissue.
7. Substantial Equivalence
MAGNETOM Vida with software syngo MR XA31A and the pulse sequence MRF is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA31A | K203443,
cleared March 31, 2021 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Vida with software syngo MR XA20A and the pulse sequence MRF is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------|------------------------------------|-----------------|--------------------|
| MAGNETOM Vida with | K192924,
cleared March 11, 2020 | LNH | Siemens Healthcare |
| syngo MR XA20A | | LNI, MOS | GmbH |
The software sequence for MRF is identical in the device software versions syngo MR XA31A and syngo MR XA20A.
8. Technological Characteristics
The MR Fingerprinting (MRF) is the one new function within software versions synqo MR XA20A and synqo MR XA31A for MAGNETOM Vida.
There are differences in technological characteristics between the subject devices and predicate devices. The underlying software (syngo MR XA20A and synqo MR XA31A) are identical to the predicate, and the inclusion of MRF is the only difference in terms of technological characteristics.
The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards
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9. Nonclinical Tests
The following performance testing was conducted on the subject device.
| Performance Test | Tested Software | Source/Rationale |
|---|---|---|
| Sample clinical images | New feature "MR Fingerprinting" | |
| with the new 2D FISP MR- | ||
| Fingerprinting pulse sequence | ||
| type as part of the software | ||
| version syngo MR XA20A and | ||
| syngo MR XA31A*. | Submission of Premarket | |
| Notifications for Magnetic | ||
| Resonance Diagnostic Devices | ||
| (November 2016) | ||
| Performance bench test | Phantom and volunteer testing | |
| for quantitative evaluation of | ||
| MRF-derived T1 and T2 values | ||
| Software verification and | ||
| validation | New feature "MR Fingerprinting" | |
| with the new 2D FISP MR- | ||
| Fingerprinting pulse sequence | ||
| type as part of the software | ||
| version syngo MR XA20A and | ||
| syngo MR XA31A. | Guidance for the Content of | |
| Premarket Submissions for | ||
| Software Contained in Medical | ||
| Devices (May 2005) |
- The tests were performed with the MR Fingerprinting (MRF) software sequence implemented in syngo MR XA20A. As the MR Fingerprinting (MRF) software sequence is identical between syngo MR XA20A and syngo MR XA31A, the clinical results are also valid for syngo MR XA31A.
For the performance test 'Sample clinical images', MRF T1 and T2 maps from volunteers were acquired to confirm the MRF sequence was executed successfully, and the resulting images were free of any obvious artifacts or degradations.
For the 'Performance bench test' repeated MRF T1 and T2 maps were acquired as part of a controlled study setup in phantom and healthy volunteers to evaluate the quantitative performance in terms of precision (repeatability and reproducibility).
The process 'Software verification and validation' comprises systematic testing according to the MRF test specification. MRF T1 and T2 maps were retrieved using on a quantitative phantom to confirm that the results were stable and parametric values were reproducible across different systems within specified ranges.
The results from each set of tests demonstrate that the devices perform as intended and is thus substantially equivalent to the predicate devices to which they have been compared.
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10. Clinical Tests
A study was performed with 3 healthy volunteers who were scanned multiple times using multiple systems to show the repeatability and reproducibility of the T1 and T2 maps acquired on the subject device and other MAGNETOM 3T scanners. In addition, several clinical patient cases were provided which demonstrated a longitudinal use case scenario, i.e., repeated scans from the same subject to observe changes over time.
The tests were performed with the MR Fingerprinting (MRF) software sequence implemented in syngo MR XA20A. As the MR Fingerprinting (MRF) software sequence is identical between syngo MR XA20A and syngo MR XA31A, the clinical results are also valid for syngo MR XA31A.
Clinical publications were referenced to provide additional clinical information on the new MR Fingerprinting method.
11.Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the devices.
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 Healthineers 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 Vida with software synqo MR XA31A and MAGNETOM Vida with software syngo MR XA20A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
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510(k) Summary - K213805
| Recognition
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 | 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, Ed.
4.0:2014 | 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.
3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971, Ed. 2:2007 | ISO |
| 5-114 | General | Medical devices – Application of
usability engineering to medical
devices | 62366, Edition
1.0:2015 | AAMI
ANSI
IEC |
| 13-32 | Software | Medical device software -
Software life cycle processes | 62304:2006 | AAMI
ANSI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4:2010 | NEMA |
| 12-288 | Radiology | Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI) | MS 9:2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20:2016 | NEMA |
12.Conclusion to Substantial Equivalence
MAGNETOM Vida with software syngo MR XA31A and the new pulse sequence MRF has the same intended use and similar technological characteristics compared to the predicate device, MAGNETOM Vida with syngo MR XA31A (K203443), with respect to the magnetic resonance features and functionalities. Similarly, MAGNETOM Vida with software syngo MR XA20A and the new pulse sequence MRF has the same intended use and similar technological
9
SIEMENS Healthineers
characteristics compared to the predicate device MAGNETOM Vida with syngo MR XA20A (K192924).
The difference between the subject device and predicate device is the addition of the new pulse sequence "MRF". The difference has been tested and the conclusions from the non-clinical and clinical data suggests that the feature bears an equivalent safety and performance profile to that of the predicate device.
Siemens believes that the addition of the new pulse sequence "MRF" to MAGNETOM Vida with software syngo MR XA31A and MAGNETOM Vida with software syngo MR XA20A is substantially equivalent to the currently marketed devices MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021) and MAGNETOM Vida with software syngo MR XA20A (K192924, cleared on March 11, 2020) respectively.