(122 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.
No
The device is described as a "magnetic resonance diagnostic device" used for producing images to assist in diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD)... These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis." This directly indicates its purpose is for diagnosis.
No
The device description explicitly states it is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet, which is a hardware component.
Based on the provided information, the MAGNETOM MR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of the internal structure and/or function of the body. It assists in diagnosis by providing images and derived parameters that are interpreted by a trained physician.
- Device Description: The device is described as a Magnetic Resonance Imaging system, which is an imaging modality used to visualize internal structures.
- Nature of the Diagnostic Information: The diagnostic information is derived from images of the patient's body, not from testing samples of biological material (like blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. The MAGNETOM MR system operates in vivo (within the living body) to produce images.
N/A
Intended Use / Indications for Use
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
LNH, MOS
Device Description
The subject device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S.
MAGNETOM Free.Max is a MRI system that has equivalencies to the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221, cleared on February 14, 2019). Whilst the subject device comes with significant new and modified hardware, the resultant customer clinical value is based on the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221).
A high level summary of the new hardware comparing to the predicate device is provided below:
Hardware New Hardware
- Magnet with no Quench Pipe including Autoramp up and Ramp down capability
- Gradient Coil and Gradient Power Amplifier
- System Cover
- Patient Table (fixed with/without vertical drive)
- RF system
- Select&GO Display (TPAN_2G) and Control Panel (CPAN_2G)
- Patient Communication Unit (Intercom with System Power On/Off Function integrated)
- Computer system
- myExam 3D Camera
New Coils
- Body Coil
- Head/Neck Coil
- Spine Coil
- BioMatrix Contour L Coil
- Contour S Coil
software syngo MR XA40A brings new/modified software features:
Software New Applications/Software Features
- Sequence Booster
- SMS Averaging
- SWI with 3D segmented EPI
- Ramp sampling mode
- Skewed SPAIR
- Accelerated Shim (STEAM-based field map)
- Deep Resolve Gain
- Deep Resolve Sharp
The following new features for the subject device are migrated from the reference software version syngo MR XA30A (K202014, September 8, 2020):
- Motion correction for Haste with multiple averages
- myExam Companion, which consists of: New Software Platform/ Workflow
- myExam 3D camera
- myExam Cockpit (new name for Dot — Cockpit)
- myExam Assist (new name for Dot | Engines)
- myExam Autopilot.
- New Scanner User Interface:
- Manual positioning
- Select&GO extension
- Guidance of general patient setup, and coil preparation
- System functional safety test
Modified Software Software Platform/ Workflow
- Improved System on/off/standby behavior
Mentions image processing
Yes, "Magnetic Resonance Imaging system", "acquisition and post processing of magnetic resonance images"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
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)
Nonclinical Tests:
- Sample clinical images: Tested Coils, new and modified software features, pulse sequence types. Conducted Image quality assessments by sample clinical images. In some cases, a comparison of the image quality / quantitative data was made for new / modified pulse sequence types and algorithms and comparison images between the new / modified features and the predicate device features. Source/Rationale: Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.
- Performance bench test: Measured SNR and image uniformity for coils, and heating measurements for coils.
- Software verification and validation: Tested mainly new and modified software features. Source/Rationale: 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 thus substantially equivalent to the predicate device to which it has been compared.
Clinical Tests / Publications:
- A clinical study of 12 individuals was conducted to practically learn Peripheral Nerve Stimulation (PNS) effects of the subject system.
- No additional clinical tests were conducted to support substantial equivalence for the subject device; however, sample clinical images were provided.
- Clinical publications were referenced to provide information on the use of SMS Averaging for TSE, Ramp sampling mode for Beat, SWI with 3D segmented EPI, Accelerated Shim (STEAM-based field map), Skewed SPAIR, Deep Resolve Gain, and Deep Resolve Sharp.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Siemens Medical Solutions USA, Inc. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A Malvern, Pennsylvania 19355
Re: K210611
Trade/Device Name: MAGNETOM Free.Max Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: May 27, 2021 Received: June 1, 2021
Dear Andrew 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
July 1, 2021
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 (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 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,
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) K210611
Device Name MAGNETOM Free.Max
Indications for Use (Describe)
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
| 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) |
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3
Section 5: 510(k) Summary
Section 5 510(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 | |
| Mail Code 65-1A | |
| Malvern, PA 19355, USA | |
| Registration Number: 2240869 |
June 30, 2021 Date Prepared:
Siemens Shenzhen Magnetic Resonance Ltd. Manufacturer: Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen PEOPLE'S REPUBLIC OF CHINA Registration Number: 3004754211
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
2. Contact Information
Andrew Turner, Requlatory 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: andrew.turner@siemens-healthineers.com
Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A
4
Device Name and Classification 3.
| Device name: | MAGNETOM Free.Max |
|---|---|
| Trade name: | MAGNETOM Free.Max |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: MOS |
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Sempra |
|---|---|
| 510(k) Number: | K183221 |
| Clearance Date: | February 14, 2019 |
| 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
The indications for use for the subject devices are within that of the predicate device:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
6. Device Description
The subject device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S.
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 triangular shape.
MAGNETOM Free.Max is a MRI system that has equivalencies to the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221, cleared on February 14, 2019). Whilst the subject device comes with significant new and modified hardware, the resultant customer clinical value is based on the predicate device MAGNETOM Sempra with syngo MR XA12 (K183221).
A high level summary of the new hardware comparing to the predicate device is provided below:
| Hardware New Hardware | - | Magnet with no Quench Pipe including
Autoramp up and Ramp down capability |
|-----------------------|---|---------------------------------------------------------------------------------------|
| | - | Gradient Coil and Gradient Power Amplifier |
| | - | System Cover |
| | - | Patient Table (fixed with/without vertical drive) |
| | - | RF system |
| | - | Select&GO Display (TPAN_2G) and Control
Panel (CPAN_2G) |
| | - | Patient Communication Unit (Intercom with
System Power On/Off Function integrated) |
| | - | Computer system |
| | - | myExam 3D Camera |
| New Coils | - | Body Coil |
| | - | Head/Neck Coil |
| | - | Spine Coil |
| | - | BioMatrix Contour L Coil |
| | - | Contour S Coil |
lole software syngo MR XA40A brings new/modified software features:
| Software | New Applications/
Software Features |
|----------|-------------------------------------------|
| | - Sequence Booster |
| | - SMS Averaging |
| | - SWI with 3D segmented EPI |
| | - Ramp sampling mode |
| | - Skewed SPAIR |
| | - Accelerated Shim (STEAM-based field map |
| | - Deep Resolve Gain |
| | - Deep Resolve Sharp |
6
Image /page/6/Picture/1 description: The image contains 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.
The following new features for the subject device are migrated from the reference software version syngo MR XA30A (K202014, September 8, 2020):
-
ı Motion correction for Haste with multiple averages
-
myExam Companion, which consists of: New Software Platform/ Workflow
-
myExam 3D camera ー
-
myExam Cockpit (new name for Dot — Cockpit)
-
myExam Assist (new name for Dot | Engines)
-
myExam Autopilot.
-
New Scanner User Interface: ।
- Manual positioning —
- Select&GO extension
- Guidance of general patient setup, and coil preparation
-
। System functional safety test
Modified Software Software Platform/ Workflow
ı Improved System on/off/standby behavior
7. Substantial Equivalence
MAGNETOM Free.Max with software syngo MR XA40A is substantially equivalent to the predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|---------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Sempra
with syngo MR XA12 | K183221,
cleared February 14, 2019 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
The subject software syngo MR XA40A is modified based on the reference software XA30A; MAGNETOM C!, which is a low field device(0.35T) with permanent magnet is listed as a reference device as well:
| Reference Devices | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|---------------------------------------|------------------|------------------------------------------------|
| MAGNETOM Aera with
syngo MR XA30A | K202014,
cleared September 8, 2020 | LNH,
LNI, MOS | Siemens AG / Siemens
Healthcare GmbH |
| MAGNETOM C! | K082331,
cleared October 1, 2008 | LNH,
MOS | Siemens Shenzhen
Magnetic Resonance
Ltd. |
7
Technological Characteristics 8.
The subject device. MAGNETOM Free.Max with software syngo MR XA40A. is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject device conforms 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 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.
9. Nonclinical Tests
| Performance Test | Tested Hardware or
Software | Source/Rationale for test |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Sample clinical images | Coils, new and modified
software features, pulse
sequence types | Guidance for Submission of
Premarket Notifications for
Magnetic Resonance
Diagnostic Devices |
| Image quality assessments
by 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 | Diagnostic Devices |
| Performance bench test | - SNR and image uniformity
measurements for coils - heating measurements for
coils | |
| Software verification and
validation | mainly new and modified
software features | Guidance for the Content of
Premarket Submissions for
Software Contained in
Medical Devices |
The following performance testing was conducted on the subject devices.
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.
10. Clinical Tests / Publications
In order to practically learn Peripheral Nerve Stimulation (PNS) effects of the subject system, a clinical study of 12 individuals were conducted (see Results of stimulation study in Appendix 3).
8
No additional clinical tests were conducted to support substantial equivalence for the subject device; 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 |
|---|---|
| SMS Averaging for TSE | [1] C. H. OH et al., 1984. Line-Integral Projection |
| Reconstruction (LPR) with Slice Encoding Techniques: | |
| Multislice Regional Imaging in NMR Tomography, IEEE | |
| Trans Med Imaging. 1984; 3(4):170-178 | |
| Ramp sampling mode | |
| for Beat | [2] Matt A.Bernstein, Kevin F.king, Xiaohong Joe Zhou, |
| Handbook Of MRI Pulse Sequences, 2004: P706-P712. | |
| SWI with 3D segmented | |
| EPI | [3] Zwanenburg JJ, et al. Fast high resolution whole brain |
| T2* weighted imaging using echo planar imaging at 7T. | |
| Neuroimage. 2011; 56:1902-1907. | |
| Accelerated Shim | |
| (STEAM-based field | |
| map) | [4] Liu W, et al. 3D Flow Compensated Interleaved EPI for a |
| Fast High-Resolution Susceptibility-Weighted Imaging at | |
| 1.5T. Proc. Intl. Soc. Mag. Reason. Med 2019; 27: 3326. | |
| [5] Nehrke, K., and Börnert, P. "DREAM—a novel approach | |
| for robust, ultrafast, multislice B1 mapping." Magnetic | |
| resonance in medicine 68.5 (2012): 1517-1526. | |
| Skewed SPAIR | [6] Hwang, T. L., van Zijl, P. C., and Garwood, M. 1999. |
| Asymmetric adiabatic pulses for NH selection. J. Magn. | |
| Reson. 138: 173-177. | |
| [7] Pfeuffer J. et al. "Zoomed Functional Imaging in the | |
| Human Brain at 7 Tesla with Simultaneous High Spatial and | |
| High Temporal Resolution” Neurolmage 17(1), 2002, p. 272- |
-
|
| Deep Resolve Gain | [8] Kellman P. et al. Image Reconstruction in SNR Units: A
General Method for SNR Measurement. MRM 2005;
54:1439. Erratum in MRM 2007; 58:311. |
| | [9] Blu T. et al. The SURE-LET approach to image denoising
IEEE Transactions on Image Processing 16(11):2778-86 |
| Deep Resolve Sharp | [10] Yulun Zhang, et al. Residual Dense Network for Image
Super-Resolution, IEEE conference on computer vision and
pattern recognition. 2018 |
| | [11] Eirikur Agustsson, Radu Timofte. NTIRE 2017
Challenge on Single Image Super-Resolution: Dataset and
Study. CVPRW, 2017. 5 |
| | [12] Justin Johnson, et al. Perceptual Losses for Real-Time
Style Transfer and Super-Resolution. European conference
on computer vision. Springer, Cham, 2016 |
Siemens MR System: MAGNETOM Free.Max(0.55T) with Software Version syngo MR XA40A
9
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 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 Free.Max with software syngo MR XA40A 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, 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 b: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 |
| 13-79 | Software | Medical device software -
Software life cycle processes | 62304:2006 +
A1:2015 | AAMI
ANSI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4:2010 | NEMA |
Traditional Premarket Notification 510(k)
10
Section 5: 510(k) Summary
| 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 |
| 2-258 | Biocompatibility | biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process
(Biocompatibility) | 10993-1:2018 | AAMI
ANSI
ISO |
12. Conclusion as to Substantial Equivalence
MAGNETOM Free.Max with software syngo MR XA40A has the same basic technological characteristics as the predicate device, MAGNETOM Sempra with syngo MR XA12, with respect to the magnetic resonance features and functionalities. And the indications for use of the subject device falls within the intended use of the predicate device.
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 Free.Max with software syngo MR XA40A is substantially equivalent to the currently marketed device MAGNETOM Sempra with software syngo MR XA12 (K183221, cleared on February 14, 2019).