(87 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (e.g., automated image analysis, segmentation, or diagnosis). The focus is on hardware (7T magnet, coils) and standard MRI image acquisition and processing.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra for diagnosis, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images and/or spectra "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states it is a "Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet" and lists various hardware components like coils. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, the MAGNETOM Terra system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, outside of the body to provide information for diagnosis, monitoring, or screening.
- MAGNETOM Terra Function: The MAGNETOM Terra system is a Magnetic Resonance Imaging (MRI) system. It produces images and spectra of the internal structure and function of the body in vivo (within the living body) using magnetic fields and radio waves. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the head or extremities and whole body. This is consistent with an imaging device, not an IVD.
Therefore, the MAGNETOM Terra system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced.
Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head.
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 device is intended for patients > 30 kg/66 lbs.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin.
Additionally the MAGNETOM Terra produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for the whole body, excluding the head.
For MAGNETOM Terra four local transmit/receive coils for the specific applications are available, these are:
1Tx32Rx Head Coil 7T Clinic; 1Tx28Rx Knee Coil 7T Clinic;
31P/1H TxRx Flex Loop 7T; 23Na 1Tx32Rx Head 7T
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Extremities, Whole body (excluding the head for Phosphorus spectroscopy)
Indicated Patient Age Range
The device is intended for patients > 30 kg/66 lbs.
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)
The following performance testing was conducted on the subject device
- o Sample clinical images or Phosphorus spectra were acquired for all modified / new pulse sequences and local coils,
- o Image quality assessments of the new Sodium head imaging capabilities, were completed during system test,
- Performance Tests according to IEC 62464-1 as well as surface heating o test for the new local coils were completed,
- Software verification and validation testing was completed in accordance ● with the FDA quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images are provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices". Clinical publications were referenced to provide information on the clinical performance of Sodium head imaging and 31P spectroscopy capabilities.
In addition to providing clinical sample images for the new features of the subject device, reports from one U.S. board-certified radiologist have been provided. The radiologist reviewed Sodium head images of heathy volunteers and patient with respect to their diagnostic quality. Comments on any observed artifacts and concerns have also been included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K173592, K172531, K102348, K102748
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Siemens Medical Solutions USA, Inc. % Milind Dhamankar, M.D. Senior Clinical Affairs Specialist 40 Liberty Boulevard MALVERN PA 19355
February 15, 2019
Re: K183222
Trade/Device Name: MAGNETOM Terra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: January 29, 2019 Received: January 30, 2019
Dear Dr. Dhamankar:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The background is plain white.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K183222 |
| Device Name | MAGNETOM Terra |
| Indications for Use (Describe) | The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of |
transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and or function of the head or extremities. Other physical parameters derived from the images may also be produced.
Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head.
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 device is intended for patients > 30 kg/66 lbs.
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."
3
Image /page/3/Picture/1 description: The image shows the word "SIEMENS" in all capital letters. The text is a teal color and is displayed horizontally. The font is sans-serif and bold.
510(k) Summary: MAGNETOM Terra
| Company: | Siemens Medical Solutions USA, Inc. |
|---|---|
| 40 Liberty Boulevard, 65-1A | |
| Malvern, PA 19355 | |
| Date Prepared: | November 19, 2018 |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Establishment Registration Number: 3002808157
Contract Manufacturers:
Quality Electrodynamics for 1Tx28Rx Knee Coil 7T Clinic coil 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143, USA Establishment Registration Number: 3007350713
Nova Medical, Inc. for 1Tx32Rx Head Coil 7T Clinic coil 150 West Street Suite 201 Wilmington, MA 01887, USA Establishment Registration Number: 3004531751
Rapid Biomedical GmbH for:
31P/1H TxRx Flex Loop 7T 23Na 1Tx32Rx Head 7T Technologiepark Wuerzburg-Rimpar Kettelerstraße 3-11 D-97222 Rimpar, Germany Establishment Registration Number: 3005049692
4
2. Contact Person:
Milind Dhamankar, M.D. Senior Clinical Affairs Specialist Siemens Medical Solutions USA, Inc. Phone: (610) 448-6467 E-mail: mailto:milind.dhamankar@siemens-healthineers.com
3. Device Name and Classification:
| Common / Usual Name | 7T Magnetic Resonance Imaging system |
|---|---|
| Trade Name | MAGNETOM Terra with syngo MR E12U |
| Classification Name | Magnetic Resonance Diagnostic Device |
| (MRDD), | |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Primary Product Code: | LNH |
| Secondary Product Code: | LNI, MOS |
4. Intended Use
The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced.
Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head.
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.
The device is intended for patients > 30 kg/66 lbs.
5
5. Device Description:
MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin.
Additionally the MAGNETOM Terra produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for the whole body, excluding the head.
For MAGNETOM Terra four local transmit/receive coils for the specific applications are available, these are:
1Tx32Rx Head Coil 7T Clinic; 1Tx28Rx Knee Coil 7T Clinic;
31P/1H TxRx Flex Loop 7T; 23Na 1Tx32Rx Head 7T
Device Modifications
The modifications that are new to the subject device supporting Sodium imaging (23Na) of the head and Phosphorus (31P) spectroscopic images and/or spectra of the whole body, excluding the head.
Hardware
Sodium Imaging of Head
- New RF Power Amplifier for Multi Nuclear Purpose: The RF transmit/receive system of the subject device is modified to enable using of two nuclei (23Na and 31P) besides H-imaging.
- New Coil: 23Na 1Tx32Rx Head 7T double resonant Head Coil for Sodium imaging of the head.
Phosphorus (31P) spectroscopy / Spectroscopic imaging for the whole body. excluding the head.
- New RF Power Amplifier for Multi Nuclear Purpose as mentioned above. ।
- New Coil: 31P/1H TxRx Flex Loop 7T double resonant loop coil for Phosphorus spectroscopy and Phosphorus imaging of the whole body excluding the head.
Software
Sodium Imaging of the Head
- New pulse sequence type UTE for Sodium head imaging is added to the subject device based on the reference device Biograph mMR with syngo MR E11P (K172531, cleared November 14, 2017)
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Image /page/6/Picture/1 description: The image shows the word "SIEMENS" in a large, sans-serif font. The text is a teal color. The background is white, which makes the text stand out.
-
Modified pulse sequence type GRE to enable Sodium head imaging.
Phosphorus (31P) spectroscopy / Spectroscopic imaging for the whole body excluding the head -
New Software Package "Multi Nuclear Spectroscopy" providing Multi -Nuclear Support and Spectroscopy Postprocessing applications identical to that of the reference device MAGNETOM Prisma with syngo MR E11C-AP04 (cleared with K173592, February 13, 2018).
-
New pulse sequence types FID and CSI FID were added to the subject । device based on the on the reference device MAGNETOM Prisma with syngo MR E11C-AP04 (cleared with K173592, February 13, 2018).
Modifications to existing software syngo MR E11K (K170840).
- Modified SPACE pulse sequence type with CAIPIRINHA acquisition technique named as CAIPIRINHA SPACE
- RESOLVE and qDWI with slice acceleration technique (SMS) -
- Further security hardening based on syngo MR E11C (latest cleared with -MR E11C-AP04 (K173592, cleared February 13. 2018)
- Dual monitor support, to support the user with more efficient use of Dot । Cockpit and post-processing parallel to the examination, a second monitor will be offered at the Acquisition Workplace.
Technological Characteristics 6.
The subject device, MAGNETOM Terra with syngo MR E12U, has different technological characteristics compared to the predicate device, MAGNETOM Terra with syngo MR E11K, (K170840 cleared October 12, 2017).
The system and its software were modified to implement new capabilities for Phosphorus spectroscopy of the whole body, excluding the head and Sodium imaging of the head. Two new local Tx/Rx coils are available to support the new applications.
The MAGNETOM Terra with syngo MR E12U conforms to the standard for software medical devices (IEC 62304:2015) and IEC as well as NEMA standards.
While there are some differences in technological characteristics between the subject device and predicate device, risk/hazard analysis and non-clinical data support that the addition of new software applications and hardware does not raise different questions of safety and effectiveness.
7. Nonclinical Tests
The following performance testing was conducted on the subject device
- o Sample clinical images or Phosphorus spectra were acquired for all modified / new pulse sequences and local coils,
7
- o Image quality assessments of the new Sodium head imaging capabilities, were completed during system test,
- Performance Tests according to IEC 62464-1 as well as surface heating o test for the new local coils were completed,
- Software verification and validation testing was completed in accordance ● with the FDA quidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
8. Clinical Tests
No additional clinical tests were conducted to support the subject device and the substantial equivalence argument; however, sample clinical images are provided to support the new coils as well as the new and modified hardware and software features of the subject device per the MR guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices". Clinical publications were referenced to provide information on the clinical performance of Sodium head imaging and 31P spectroscopy capabilities.
In addition to providing clinical sample images for the new features of the subject device, reports from one U.S. board-certified radiologist have been provided. The radiologist reviewed Sodium head images of heathy volunteers and patient with respect to their diagnostic quality. Comments on any observed artifacts and concerns have also been included.
Safety and Effectiveness 9.
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The MAGNETOM Terra with syngo MR E12U conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following table.
8
| 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 | 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. 3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of risk
management to medical devices | 14971 Second
edition 2007-
03-01 | ISO |
| 5-96 | General | Medical devices - Application of
usability engineering to medical
devices | 62366-1:2015 | AAMI ANSI
IEC |
| 13-79 | Software | Medical device software - Software
life cycle processes | 62304 Edition
1.1 2015-06 | IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing Magnetic
Resonance Imaging Devices | MS 4-2010 | NEMA |
| 12-300 | Radiology | Digital Imaging and Communications
in Medicine (DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-156 | Biocom-
patibility | Biological evaluation of medical
devices -- part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-
1:2009/(R)
2013 | AAMI
ANSI
ISO |
10. Substantial Equivalence
MAGNETOM Terra with syngo MR E12U includes most of the features of the predicate device and additional new and modified hardware and software as noted below.
9
| Predicate Device | FDA Clearance
Number and Date | Product
Code | Manufacturer |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------|--------------------------------------------|
| MAGNETOM Terra with syngo
MR E11K
Please note the following parts of the
MAGNETOM Terra System are the predicate
device parts related to:
• System Architecture
• RF transmit/receive system
• Gradient System
• SAR Management and Control System
• Computer Systems
• Software syngo MR E12U
• Local Coils
• Patient table
• Magnet
• Cover
• Physiological Measurement Devices
• Patient communication devices | K170840 cleared
October 12, 2017 | LNH,
LNI,
MOS | Siemens AG /
Siemens
Healthcare GmbH |
| Reference Devices | FDA Clearance
Number and Date | Product
Code | Manufacturer |
| MAGNETOM Prisma with syngo
MR E11C-AP04
Please note the following parts of the
MAGNETOM Prisma are the reference device
parts related to:
• Multi Nuclear Option
• Spectroscopy
• Security Improvements
• Dual Monitor Support
• SPACE with CAIPIRINHA acquisition
technique | K173592, cleared
February 13,
2018 | LNH,
LNI,
MOS | Siemens AG /
Siemens
Healthcare GmbH |
| Biograph mMR with syngo MR
E11P
Please note the following parts of the Biograph
mMR are the reference device parts related to:
• Pulse sequence type | K172531, cleared
November 14,
2017 | OUO,
LNH,
LNI,
KPS | Siemens AG /
Siemens
Healthcare GmbH |
| 31P/1H Dual Tuned Surface Coil
3T
Reference device parts related to:
31P/1H TxRx Flex Loop 7T double resonant
loop coil for Phosphorus spectroscopy of the
body and extremities | K102348, cleared
December 22,
2010 | MOS | Rapid Biomedical
GmbH |
| 23Na/1H Head Coil 3T
Reference device parts related to:
23Na 1Tx32Rx Head 7T double resonant
Head Coil for Sodium imaging of the head | K102748, cleared
May 13, 2011 | MOS | Rapid Biomedical
GmbH |
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12. Conclusion as to Substantial Equivalence
The modifications to the MAGNETOM Terra with syngo MR E12U do not alter the fundamental scientific technology of the magnetic resonance diagnostic device. The modifications extends capability of the cleared MAGNETOM Terra (K170840) to include Phosphorus (31P) spectroscopic capabilities for whole body excluding the head as well as Sodium (23Na) head imaging. These capabilities are a subset of the general use of a MRDD, rather than a new intended use and adds no significant risk to the general Indications for Use of the MAGNETOM Terra.
The MAGNETOM Terra with syngo MR E12U has different technological characteristics than the predicate device, MAGNETOM Terra with syngo MR E11K (K170840 cleared October 12, 2017), with respect to the Phosphorus spectroscopy and Sodium head imaging.
The predicate device was cleared based on non-clinical supportive information and clinical images and data. The comparison of technological characteristics, non-clinical performance data, software validation data, and supporting literature for the clinical performance of Sodium head imaging and Phosphorus spectroscopy demonstrates that the modifications to the predicate device will be as safe and effective when compared to the predicate device that is currently marketed for the same general intended use. Therefore the subject device is substantially equivalent to the predicate device.
summary, MAGNETOM Terra with syngo MR E12U has extended ln functionalities compared to the predicate device and within the general intended use. Based on the aforementioned information the modifications do not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Terra with syngo MR E12U does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Terra with syngo MR E11K (K170840 cleared October 12, 2017).