(49 days)
No
The document describes new and modified software features for an MRI system, but none of the descriptions explicitly mention the use of AI or ML algorithms. The "Prostate Dot Engine" mentions a "segmentation algorithm described and cleared with syngo.via VB40," but this does not necessarily imply AI/ML.
No
The "Intended Use / Indications for Use" section clearly states that the system is a "magnetic resonance diagnostic device (MRDD)" used to produce images and spectra that "may assist in diagnosis." It does not mention any therapeutic use.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the system is indicated for use as a "magnetic resonance diagnostic device (MRDD)" and that the "information ... may assist in diagnosis."
No
The device description explicitly states that the system includes "new and modified hardware and software" and lists "New Computer" under the Hardware section. This indicates it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the body. It explicitly mentions that the information derived from these images and spectra, when interpreted by a trained physician, assists in diagnosis.
- Nature of the Device: The device is an MRI system, which is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body.
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on samples taken from the body.
The device is a diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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, vield 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
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A, include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA20A. A high-level summary of the new and modified hardware and software is provided below:
Hardware
- New Computer
Software New Features and Applications - SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
- BEAT_FQ_nav is a pulse sequence that allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating and flow imaging are cleared features available on the predicate device. However, the combination of the two is new.
- Injector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast iniection and examination start.
- The Prostate Dot Engine provides an assisted and guided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage based on the segmentation algorithm described and cleared with syngo.via VB40; this may support exams not having to be repeated.
Modified Features and Applications - An optimized high bandwidth inversion recovery pulse is combined with gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
Other Modifications and / or Minor Changes - Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver.
- HASTE MoCo is an image-based motion correction function in the averagedimension for the HASTE pulse sequence type.
- Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
Mentions image processing
Yes
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
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)
The following performance testing was conducted on the subject devices.
- Sample clinical images: Tested on coils, new and modified software features.
- Image quality assessments using sample clinical images: Tested on new/modified pulse sequence types and algorithms and comparison images between the new/modified features and the predicate device features. Source/Rationale for test: Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
- Performance bench test: Tested on new and modified hardware.
- Software verification and validation: Tested on new and modified software features. Source/Rationale for test: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The results from each set of tests demonstrate that the devices perform as intended and are therefore, substantially equivalent to the predicate device to which it has been compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
September 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Mr. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
Re: K202014
Trade/Device Name: MAGNETOM Aera, MAGNETOM Skyra, Magnetom Prisma/Prismafit with syngo MR XA30A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: July 17, 2020 Received: July 21, 2020
Dear Mr. Turner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma Fit with syngo MR XA30A
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional 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, vield 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Image /page/3/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. The background is a light gray color.
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.
-
- General Information
| Establishment: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 17, 2020 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestrasse 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
Andrew Turner, Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355, USA Phone: (610) 850-5627 Fax: (610) 448-1787 E-mail:
Traditional Premarket Notification 510(k)
July 17, 2020
Siemens MR Systems: MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A
4
Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
3. Device Name and Classification
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Device/Trade name: Prisma/ Prismafit with syngo SW XA30A
| 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. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K192924 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
|---|---|
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNL MOS |
5. Intended Use
The indications for use for the subject devices are the same as the predicate device:
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.
Traditional Premarket Notification 510(k)
Siemens MR Systems: MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A
5
Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
6. Device Description
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A, include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA20A. A high-level summary of the new and modified hardware and software is provided below:
Hardware
- New Computer
Software
New Features and Applications
- SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
- BEAT_FQ_nav is a pulse sequence that allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating and flow imaging are cleared features available on the predicate device. However, the combination of the two is new.
- Injector coupling is a software application that allows the connection of । certain contrast agent injectors to the MR system for simplified, synchronized contrast iniection and examination start.
- -The Prostate Dot Engine provides an assisted and guided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage based on the segmentation algorithm described and cleared with syngo.via VB40; this may support exams not having to be repeated.
Modified Features and Applications
- i An optimized high bandwidth inversion recovery pulse is combined with gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
Other Modifications and / or Minor Changes
- Elastography-AddIn synchronizes settings between the Elastography i sequence and the active driver.
- HASTE MoCo is an image-based motion correction function in the averagedimension for the HASTE pulse sequence type.
- Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
Siemens MR Systems: MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A
6
Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots in a circular pattern.
7. Substantial Equivalence
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A are substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA20A | K192924,
cleared March 11, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A include hardware and software already cleared on the following reference devices:
| Reference Devices | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|-------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------|-----------------------------------------|
| MAGNETOM Aera,
MAGNETOM Skyra and
MAGNETOM Prisma/
Prismafit with software
syngo MR VE11C | K153343,
cleared April 15, 2016 | LNH
LNI, MOS | Siemens AG / Siemens
Healthcare GmbH |
| syngo.via VB40 | K192462,
Cleared January 31, 2020 | LLZ, LNH | Siemens Healthcare
GmbH |
Technological Characteristics 8.
The subject devices, MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prismall with software syngo MR XA30A, 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.
As seen above there are some differences in technological characteristics between the subject devices and predicate device, including different hardware and modified software. These differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.
Siemens MR Systems: MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/it (1.5 / 3T) with new Software syngo MR XA30A
7
Image /page/7/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Sample clinical images | Coils, new and modified software features | |
| Image quality assessments using sample clinical images. In some cases, a comparison of the image quality / quantitative data was made. | - new / modified pulse sequence types and algorithms. |
- comparison images between the new / modified features and the predicate device features | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices |
| Performance bench test | new and modified hardware | |
| Software verification and validation | new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
The results from each set of tests demonstrate that the devices perform as intended and are therefore, substantially equivalent to the predicate device to which it has been compared.
10. 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. Clinical publications were referenced to provide information on the use of the following features and functions.
| Feature / Function | Clinical Publication |
|---|---|
| SVS_EDIT | [1] Mescher et al, Simultaneous in vivo spectral editing and water |
| suppression, NMR Biomed 11, 266-272 (1998) | |
| [2] Mikkelsen et al, Big GABA: Edited MR spectroscopy at 24 research | |
| sites, Neurolmage 159, 32-45 (2017) | |
| [3] Saleh et al, Multi-vendor standardized sequence for edited magnetic | |
| resonance spectroscopy, Neurolmage 189, 425-431 (2019) | |
| Prostate Dot Engine | [7] Essner M. Zinsser D, Kündel M, et. al. Performance of an Automated |
| Workflow for Magnetic Resonance Imaging of the Prostate: Comparison | |
| With a Manual Workflow. Invest Radiol. 2020 May;55(5):277-284. Doi: | |
| 10.1097. | |
| [8] Horger W, Thoermer G, Weiland E, et. al. Prostate Dot Engine – a | |
| system guided and assisted workflow to improve consistency in prostate | |
| MR exams. | |
| [9] Yadong C, Siyuan H, Chunmei Li, et. al. Performance and | |
| Reproducibility of a Day Optimizing Throughput (Dot) Workflow Engine in | |
| Automated Prostate MRI Positioning. Abstract accepted for the 28th | |
| annual meeting of the International Society of Magnetic Resonance in | |
| Medicine (ISMRM). |
Traditional Premarket Notification 510(k)
July 17, 2020
Siemens MR Systems: MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A
8
Image /page/8/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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 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 and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A conform to the following FDA recognized and international IEC, ISO and NEMA standards:
| 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 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 |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971: 2007 | ISO |
| 5-114 | General | Medical devices - Application of
usability engineering to medical
devices | 62366-1:2015 | AAMI
ANSI
IEC |
Traditional Premarket Notification 510(k)
July 17, 2020
Siemens MR Systems: MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A
9
Image /page/9/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. The background is a light gray color.
| 13-79 | Software | Medical device software -
Software life cycle processes | 62304 Edition 1.1
2015-06 | 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 |
| 2-220 | Biocompati
bility | biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process
(Biocompatibility) | 10993-1: 2009 | AAMI
ANSI
ISO |
12. Conclusion as to Substantial Equivalence
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/11 with software syngo MR XA30A have the same intended use and same basic technological characteristics as the predicate device system, MAGNETOM Vida with syngo MR XA20A, 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 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 and MAGNETOM Prisma/ Prismall with software syngo MR XA30A are substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA20A (K192924, cleared on March 11, 2020).
Traditional Premarket Notification 510(k)
Siemens MR Systems: MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ Prismafit (1.5 / 3T) with new Software syngo MR XA30A