(21 days)
No
The document describes minor hardware modifications and adaptations for mobility, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The intended use clearly states it is for diagnostic purposes, producing images and spectra to assist in diagnosis, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)". It further elaborates that the images and/or spectra produced "yield information that may assist in diagnosis."
No
The device description explicitly states "minor modified hardware compared to the predicate device" and lists "Cover" as modified hardware, indicating it is not software-only.
Based on the provided information, the MAGNETOM system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician. This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
- Device Description: The description details hardware modifications and its use as a mobile MRI system. This aligns with an in vivo imaging device.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in vivo imaging technique.
- Anatomical Site: The device is used on the "head, body, or extremities," which are all parts of the living organism.
IVD devices are typically used to examine samples such as blood, urine, tissue, etc., outside of the body to provide diagnostic information. The MAGNETOM system operates by imaging the patient directly.
N/A
Intended Use / Indications for Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Cover
Other Modifications and / or Minor Changes
- Adaptations for installation in a mobile trailer
- MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Interventional procedures; mobile trailer
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: Performance bench test (modified hardware), Verification and validation (modified hardware), Electrical safety and electromagnetic compatibility (EMC) (complete system). The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared. No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device.
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 contains 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 the FDA logo, which 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.
September 6, 2023
Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K232482
Trade/Device Name: MAGNETOM Viato.Mobile Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: August 15, 2023 Received: August 16, 2023
Dear Alina Goodman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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
1
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 (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 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,
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
Submission Number (if known)
Device Name
MAGNETOM Viato.Mobile
Indications for Use (Describe)
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
e-Counter Use (21 CFR 801 Subpart C)
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3
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: | August 15, 2023 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestrasse 127
91052 Erlangen
Germany
Registration Number: 3002808157 |
2. Contact Information
Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1 (224) 526-1404 E-mail: alina.goodman@siemens-healthineers.com
Device Name and Classification 3.
| Device/ Trade name: | MAGNETOM Viato.Mobile |
|---|---|
| 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
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Sola Fit |
|---|---|
| 510(k) Number: | K221733 |
| Clearance Date: | December 13, 2022 |
| 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 |
Intended Use / Indications for Use 5.
The indications for use for the subject device is the same as the predicate device:
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
6. Device Description
MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Cover
Other Modifications and / or Minor Changes
- Adaptations for installation in a mobile trailer
5
- । MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.
7. Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola Fit with
syngo MR XA51A | K221733,
cleared December 13, 2022 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Viato.Mobile with software syngo MR XA51A includes hardware already cleared on the following reference devices:
| Reference Devices | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Aera with
software syngo MR XA30A
Please note: the Mobile Solution,
as part of MAGNETOM Aera with
software syngo MR XA30A, is the
reference device related to
modifications performed to fit the
subject device to the mobile
environment. | K202014,
cleared September 8, 2020 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Avanto Fit
with software syngo MR
XA50A
Please note: reference device
related to the cover | K220151,
cleared April 1, 2022 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
Comparison of technological Characteristics with the Predicate Device 8.
The subject device, MAGNETOM Viato.Mobile with software syngo MR XA51A, is substantially equivalent to the predicate device with regard to the operational environment, programming lanquage, 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 no differences in technological characteristics between the subject device and predicate device, but minor modified hardware and an installation in a mobile trailer, these differences have been tested and the conclusion from the non-clinical data suggests that the system bears an equivalent safety and performance profile to that of the predicate device.
6
Nonclinical Tests 9.
The following performance testing was conducted on the subject device.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Performance bench test | modified hardware | Guidance for Submission of |
| Premarket Notifications for | ||
| Magnetic Resonance | ||
| Diagnostic Devices | ||
| Verification and validation | modified hardware | Guidance for the Content of |
| Premarket Submissions for | ||
| Software Contained in Medical | ||
| Devices | ||
| Electrical safety and | ||
| electromagnetic compatibility | ||
| (EMC) | complete system | IEC 60601-1-2 |
The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
10. Clinical Tests / Publications
No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device.
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 cvcle 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 Viato.Mobile with software syngo MR XA51A conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
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| Recognition
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/ EMC) | Medical electrical equipment -
Part 1: General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012
and
A2:2010/(R)2012
(Consolidated Text) | ANSI AAMI |
| 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 |
| 5-125 | General I
(QS/ RM) | Medical devices - Application of
risk management to medical
devices | 14971 Third Edition
2019-12 | ISO |
| 5-114 | General I
(QS/ RM) | Medical devices - Part 1:
Application of usability
engineering to medical devices
[Including CORRIGENDUM 1
(2016)] | 62366-1 Edition 1.0
2015-02 | IEC |
| 13-79 | Software/
Informatics | Medical device software -
Software life cycle processes | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | IEC |
| 2-258 | Biocompati
bility | Biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process | 10993-1 Fifth
edition 2018-08 | ISO |
| 12-342 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.20
2021e | NEMA |
| 12-188 | Radiology | Determination of Signal-to-
Noise Ratio (SNR) in Diagnostic
Magnetic Resonance Images | MS 1:2008 (R2020) | NEMA |
| 12-196 | Radiology | Determination of Two-
dimensional Geometric
Distortion in Diagnostic
Magnetic Resonance Images | MS 2:2008 (R2020) | NEMA |
| 12-187 | Radiology | Determination of Image
Uniformity in Diagnostic
Magnetic Resonance Images | MS 3:2008 (R2020) | NEMA |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4:2010 | NEMA |
| 12-322 | Radiology | Determination of Slice
Thickness in Diagnostic
Magnetic Resonance Imaging | MS 5:2018 | NEMA |
| 12-195 | Radiology | Determination of Signal-to-
Noise Ratio and Image
Uniformity for Single-Channel,
Non-Volume Coils in Diagnostic
Magnetic Resonance Imaging
(MRI) | MS 6:2008 (R2014) | NEMA |
| 12-315 | Radiology | Characterization of the Specific
Absorption Rate for Magnetic
Resonance Imaging Systems | MS 8:2016 | NEMA |
| 12-288 | Radiology | Standards Publication
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images | MS 9-2008 (R2020) | NEMA |
| 12-298 | Radiology | Determination of Local Specific
Absorption Rate (SAR) in
Diagnostic Magnetic Resonance
Imaging Systems | MS 10 - 2010 | NEMA |
| 12-306 | Radiology | Quantification and Mapping of
Geometric Distortion for Special
Applications | MS 12 - 2016 | NEMA |
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12. Conclusion as to Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Sola Fit with syngo MR XA51A, with respect to the magnetic resonance features and functionalities. There are no differences in technical features compared to the predicate device, but minor modified hardware and an installation in a mobile trailer. The resulting differences have been tested and the conclusions from all verification and validation data suggest that the system bears an equivalent safety and performance profile to that of the predicate device and reference devices.
Siemens believes that MAGNETOM Viato.Mobile with software syngo MR XA51A is substantially equivalent to the currently marketed device MAGNETOM Sola Fit with software syngo MR XA51A (K221733, cleared on December 13, 2022).