MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Device Description

Like the previously cleared device K190524, the actual MRopen EVO is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.

Modification of K190524 cleared device.

. New commercial name (hence labeling is amended)
. Different cover colours from light blue to grey
. Changes in labelling due to above changes

MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

AI/ML Overview

This FDA 510(k) summary for the MRopen EVO device states that no new testing was performed to establish acceptance criteria or device performance, as the changes from the predicate device (MRopen 0.5 T, K190524) were limited to a new commercial name and different cover colors. The submission relies entirely on the safety and effectiveness data provided for the predicate device.

Therefore, many of the requested details cannot be extracted directly from this document regarding the MRopen EVO. However, based on the information provided, we can infer the following about the approach taken for the MRopen EVO and, by extension, the predicate device it references:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format for the MRopen EVO. Instead, it asserts substantial equivalence to the predicate device (MRopen 0.5 T, K190524) because the changes are only cosmetic (name and color). The performance is therefore assumed to be identical to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided for the MRopen EVO or explicitly detailed for the predicate device within this summary. The summary states that "non clinical (bench) and clinical (healthy volunteers) data supplied within K190524 file" were used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The MRopen EVO is a magnetic resonance diagnostic device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI-assisted reading would not be applicable or expected for this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The MRopen EVO is a medical imaging device, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not explicitly provided. The summary mentions that images produced by the device "can yield information that can be useful in the determination of a diagnosis" when interpreted by a "trained physician," implying that clinical diagnosis by qualified medical professionals would establish ground truth for the predicate device's performance.

8. The sample size for the training set

This information is not applicable as the MRopen EVO is an imaging device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable.

Summary of the Acceptance Criteria and Study for MRopen EVO based on the provided document:

Feature	Acceptance Criteria	Reported Device Performance
Device Performance (Overall)	To be as safe, as effective, and to perform as well as or better than the legally marketed predicate device (MRopen 0.5 T, K190524).	The MRopen EVO, with only cosmetic changes (commercial name and cover colors) from the predicate device, is asserted to be as safe, as effective, and to perform as well as the predicate device (MRopen 0.5 T, K190524). No new performance data was presented for MRopen EVO. Performance is functionally identical to the predicate.
Test Set Sample Size & Provenance	Not explicitly stated for specific tests for either MRopen EVO or its predicate. Clinical data for the predicate (K190524) referred to as "healthy volunteers" and "non clinical (bench)" data.	Not applicable for MRopen EVO as no new testing was performed. Information for the predicate device's clinical and non-clinical data is not detailed in this summary.
Ground Truth Experts/Qualifications	Not applicable, as no new testing was conducted for MRopen EVO, and details for the predicate are not included. Interpretation by "trained physician" for diagnosis is mentioned for the predicate.	Not applicable for MRopen EVO.
Adjudication Method	Not applicable.	Not applicable.
MRMC Comparative Effectiveness Study	Not applicable. The device is a diagnostic imaging system, not an AI-assisted reading tool.	Not applicable.
Standalone Performance (Algorithm)	Not applicable. The device is a medical imaging system, not an algorithm.	Not applicable.
Type of Ground Truth	For the predicate device, implied to be clinical diagnosis based on images interpreted by trained physicians.	Not applicable for MRopen EVO. For the predicate, presumed clinical diagnosis by trained physicians.
Training Set Size	Not applicable. The device is an imaging system, not an AI algorithm.	Not applicable.
Training Set Ground Truth Method	Not applicable. The device is an imaging system, not an AI algorithm.	Not applicable.

Conclusion:

This 510(k) submission for the MRopen EVO is a Special 510(k) primarily focused on demonstrating substantial equivalence to its predicate (MRopen 0.5 T, K190524) based on the limited nature of the proposed changes (commercial name and cover colors). Consequently, the document explicitly states that no new non-clinical or clinical testing was deemed necessary. All safety and effectiveness claims for the MRopen EVO rely on the data previously submitted and reviewed for the predicate device. Therefore, this document does not contain the detailed study information (sample sizes, expert qualifications, ground truth methods, etc.) that would typically be found for a device undergoing de novo testing or significant modifications.

Summary

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a stylized human figure on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size than the rest of the text.

ASG Superconductors S.p.A. % Luisella De Benedetti QA/RA Consultant Corso Ferdinando Maria Perrone 73/R Genova. 16152 ITALY

December 20, 2019

Re: K193116

Trade/Device Name: MRopen EVO Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: November 4, 2019 Received: November 12, 2019

Dear Luisella De Benedetti:

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

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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

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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)

K193116

Device Name MRopen EVO

Indications for Use (Describe)

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.

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."

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Image /page/3/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is composed of curved lines in blue, yellow, green, orange, and red. The text "ASG SUPERCONDUCTORS" is in blue and is to the right of the graphic.

9. 510(k) Summary (21 CFR 807.92)

2019 Date: (month/day/year) 11

807.92(a)(l) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;

Submitter Information

ASG Superconductors S.p.A. Name Address Corso Perrone 73R - 16152 Genova, Italy

+39 010 6489 358 Telephone n.
Contact Person Luisella De Benedetti ASG Superconductors S.p.A. Corso F.M. Perrone 73R 16152 Genova +39 010 6489 358 debenedetti.luisella@as-g.it

807.92(a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Name of the device	MRopen EVO
Trade name	ASG Superconductors
Classification name	Total Body Magnetic Resonance Diagnostic Device
Classification and class of device	21 CFR 892.1000, class II
Classification Number	90LNH

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Image /page/4/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized symbol on the left, resembling overlapping arcs in different colors, followed by the text "ASG" in a bold, blue font. Below "ASG", the word "SUPERCONDUCTORS" is written in a smaller, blue font.

807.92(a)(3) An identification of the legally marketed device to which the submitter claims equivalence.

PREDICATE (for all items excluded the below specified) ASG Superconductors S.p.A. MRopen 0.5T K190524

807.92(a)(4) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;

Modification of K190524 cleared device.

. New commercial name (hence labeling is amended)
. Different cover colours from light blue to grey
. Changes in labelling due to above changes

MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

The modification reflected in this Special 510(k) for the MRopen EVO Tomograph are detailed in below table.

. New commercial name (hence labeling is amended)
. Different cover colours

Image /page/4/Picture/15 description: The image shows a blue quarter-circle shape in the lower right corner. The rest of the image is white. The blue shape is a solid color and has a smooth, curved edge.

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Image /page/5/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is composed of curved lines in blue, red, yellow, and green. The text "ASG" is in a large, bold, blue font, and the word "SUPERCONDUCTORS" is in a smaller, blue font below the letters "ASG".

807.92(a)(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in paragraph (a) (3) of this section, the 510 (k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled;

MRopen EVO product is a Magnetic Resonance Diagnostic Device like previous K190524 MRopen 0.5 T model.

MRopen EVO product is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging like previous K190524 MRopen 0.5 T model.

MRopen EVO Tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the anatomies. The examinations may be performed both in weight free (supine) and weight bearing position like previous K190524 MRopen 0.5 T model.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

Intended population is for Patients less than 200 Kg

The MRopen EVO Tomograph, like previous K190524 MRopen 0.5 T model, can perform DWI images based on a Diffusion excitation pattern applied on a specific acquisition sequence, in this case the HASTE readout sequence. DWI is a well known diagnostic technique which does not rise safety and effectiveness issues different form the previously addressed ones when used as labeled.

In next page we include the IFU statement from K190524 MRopen 0.5 T predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the company name. The graphic consists of a series of curved lines in different colors, including blue, green, yellow, and red. The company name is written in blue, with the word "ASG" in a larger font size than the word "Superconductors."

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)K190524	K190524
Device NameMRopen 0.5 T

Indications for Use (Describe)

MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast inaging. MRopen 0.5 T tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the intemal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (11), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.

807.92(a)(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device identified in paragraph (a) (3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in paragraph (a) (3) of this section

Technological Characteristics

The MRopen EVO MRI system is substantially equivalent to MRopen 0.5 T K190524 except commercial name and cover colours.

General item	MRopen EVO	Predicate K190524MrOpen 0.5 T
Anatomical regions	Total body with the following limitation: no cardiac imaging, no breast imaging.
Nucleus excited	Proton (hydrogen nucleus)
Diagnostic uses	Magnetic Resonance Diagnostic Device
SCOUT Multiplanar Ortogonal (SE o GFE)	Yes
Spin echo T1 (SET1)	Yes
Spin echo T2 (SET2)	Yes
Short TE spin echo (ERASE)	Yes
General item	MRopen EVO	Predicate K190524MrOpen 0.5 T
Double echo (DE)		Yes
Inversion recovery (IR)		Yes
Short TAU inversion recovery(STIR)		Yes
Short time inversion recoverygradient field echo (GFE-STIR)		Yes
Gradient Field Echo (GFE)		Yes
Gradient Field Echo 3D (3D-GFE)		Yes
RF spoiled gradient echo 3D (3D-SPGFE)		Yes
Time reversed 3D gradient FieldEcho (3D-EMIT)		Yes
Rapid Imaging SE T2 (RISE)		Yes
Rapid Imaging DE (RIDE)		Yes
Fast Inversion Recovery (FIR)		Yes
FLAIR - Fluid attenuated InversionRecovery		Yes
Spin Echo Presat - FAST RISE9PRESAT		Yes
Fast Rise (up to 16 echoes)		Yes
Fast PD (Fast proton density)		Yes
3D Gradient Balanced Steady State(3D-GBASS)		Yes
Fat-Water separation T1 (FWS T1)		Yes
ANGIO sequences		Yes
HASTE sequence		Yes
DWI technique		Yes
Magnetic system	High homogeneity Open-sky Magnet, based on hightemperature cryogenless superconductive, horizontalfield
		Maximum Magnetic field 0.5 Tesla
	Current 146A
		28000 kg
		200x200x170 cm (HxDxW)
General item	MRopen EVO	Predicate K190524MrOpen 0.5 T
	4.0 x 4.6 x 3.6 m (Vertical x Transversal xLongitudinal)
	<2 ppm FWHM over 30 cm DSV
Gantry	56 cm lateral gap
Gradient System	20mT/m
	0.6 msec (from 0 - 20 mT/m)
	33 mT/m/ms
	9 kW
RF amplifier	Analogic AN8102 orRFT RF9200 model as alternative
Spectrometer	ACS MRIBox
Covers colour	White
	3M 1080-S261 DarkGrey	Light blue Pantone 285

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Image /page/7/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is a series of curved lines in different colors, including blue, green, yellow, and red. The text "ASG" is in large, blue letters, and the word "SUPERCONDUCTORS" is in smaller, blue letters below "ASG".

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Image /page/7/Picture/3 description: The image shows a close-up of a blue shape. The shape is a curved, rounded form that takes up a significant portion of the image. The color is a solid, deep blue, and the shape appears to be smooth and without texture. The composition is simple, focusing solely on the blue shape against what appears to be a white or light background.

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Image /page/8/Picture/0 description: The image shows the logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of curved lines in blue, green, yellow, and red. The text "ASG SUPERCONDUCTORS" is in blue, with "ASG" in a larger font than "SUPERCONDUCTORS".

ReceivingCoils' list	Code#autom.Recogn. digit	MRopen EVO	Predicate K190524MrOpen 0.5 T
C-Spine	03-2003 #7	✓ available in light blue ordark grey	✓ available in light blue
Shoulder	03-2005 #9	✓ available in light blue ordark grey	✓ available in light blue
Hand	03-2006 #4	✓ available in light blue ordark grey	✓ available in light blue
MP-Loop	03-2010 #8	✓ available in light blue ordark grey	✓ available in light blue
Flex S	03-2011 #12	✓ available in light blue ordark grey	✓ available in light blue
Flex L	03-2012 #13	✓ available in light blue ordark grey	✓ available in light blue
MP_Flat	03-2015 #14	✓ available in light blue ordark grey	✓ available in light blue

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Image /page/9/Picture/0 description: The image is a logo for ASG Superconductors. The logo features a stylized graphic to the left of the text. The graphic is made up of several curved lines in different colors, including blue, green, yellow, and red. The text "ASG" is in a large, bold, blue font, and the text "SUPERCONDUCTORS" is in a smaller, blue font below the "ASG" text.

ReceivingCoils' list	Code#autom.Recogn. digit	MRopen EVO	Predicate K190524MrOpen 0.5 T
Body	03-2019 #2	✓ available in light blue or dark grey	✓ available in light blue
Knee	03-2018#3	✓ available in light blue or dark grey	✓ available in light blue
Head	03-2001#1	✓ available in light blue or dark grey	✓ available in light blue
Head/Neck	03-2020#10	✓ available in light blue or dark grey	✓ available in light blue
Spine	03-2016#8	✓ available in light blue or dark grey	✓ available in light blue
Long Spine	03-2100#11	✓ available in light blue or dark grey	✓ available in light blue
Shoulder	03-2101#9	✓ available in light blue or dark grey	✓ available in light blue

(b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information:

(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;

Being the proposed changes only referred to Commercial name and colours we do not consider necessary performing new testing with respect to those attached to K190524 cleared file.

(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific

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reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and

Being the proposed changes only referred to Commercial name and colours we do not consider necessary performing new testing with respect to those attached to K190524 cleared file.

(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a) (3) of this section.

Being that proposed change doesn't affect performance of the device we conclude that the non clinical (bench) and clinical (healthy volunteers) data supplied within K190524 file demonstrate both MRopen 0.5T and MRopen EVO to be as safe, as effective and that it also performs as well than the predicate. Mropen EVO is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards being different just in name and in colours from the predicate MRopen 0.5 T K190524.

Regulation Number and Section

§ 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.