MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T 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 (Tl), 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 K151466, the actual MRopen 0.5 T 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 K151466 cleared device.

Introduce DWI technique based on HASTE readout sequence 0
Introduce internally developed User Interface 0
Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA
0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
Long Spine receiving coil o
0 Shoulder coil new model
Changes to patient support shapes and courtesy cushions o

MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T 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 Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.

AI/ML Overview

The provided text describes modifications to an existing MRI device (MRopen 0.5 T) and its substantial equivalence to predicate devices, focusing on hardware and software updates, including the introduction of a DWI technique. However, it does not explicitly detail the acceptance criteria for these modifications or a specific study proving the device meets those criteria in the way typically required for a classification of an AI/ML-enabled medical device.

The document states "No clinical tests were performed" for the purpose of demonstrating substantial equivalence in the conventional sense. Instead, it refers to images of healthy volunteers to demonstrate the performance of the device on humans for the new DWI technique and new coils.

Here's an attempt to extract the requested information based on the provided text, acknowledging the limitations for certain points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria typical for complex AI/ML device performance. Instead, it discusses image quality and performance in a qualitative manner, referencing clinical utility and comparison to predicate devices for specific features.

Feature Tested	Acceptance Criteria (Inferred from Rationale)	Reported Device Performance (Qualitative)
New DWI technique (HASTE readout)	Image quality conformant to expected for diagnostic use	"The images on healthy volunteers conform to the expected image quality. Both ADC calculated image and DWI images along the three main directions are displayed."
New Long Spine coil	Equivalent or better image quality to previous model, workflow improvement.	"The use of this new receiving coil has been referred to the previous spine model for equivalent or better quality image, with the workflow improvement of not new coil positioning in case of multiple scan of different streches of spine."
Shoulder coil New model	Design equivalent to K122034 predicate, better fit with new accessories.	"This design is exactly the same employed in MrJ 3300 secondary predicate device which better fits the new patient comfort accessories during shoulder exam."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: "The healthy volunteers were adult male and female aged between 20 and 60 available in our firm." The exact number is not specified, but it implies a small, internal cohort.
Data Provenance: The healthy volunteers were "available in our firm," suggesting internal, prospective data collection from individuals affiliated with the company. The country of origin is presumably Italy, where ASG Superconductors S.p.A. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not specified. The document states, "When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis." This implies interpretation by a physician but does not detail the number or role of experts in establishing ground truth for the test set explicitly.
Qualifications of Experts: Assumed to be "trained physician(s)" as stated in the intended use. Specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

Adjudication method: Not specified. Given the qualitative nature of the "results/remarks," it's unlikely a formal adjudication method was employed as would be typical for an AI/ML diagnostic system. The evaluation seems to be based on direct assessment of image quality and clinical utility.

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

A MRMC comparative effectiveness study was not performed, nor is it applicable to this submission. The device is a diagnostic imaging system (MRI), not an AI-assisted diagnostic tool for image interpretation. The submission is for hardware and software updates to an existing MRI machine.

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

A standalone algorithm performance study was not performed, nor is it applicable. This is an MRI system, which produces images for physician interpretation, not an algorithm that provides a standalone interpretation or diagnosis.

7. The Type of Ground Truth Used

For the performance evaluation of the DWI technique and new coils, the "ground truth" was qualitative assessment of image quality from healthy volunteers compared to expected diagnostic image quality from established techniques and coils. It is not based on pathology, outcomes data, or formal expert consensus in the typical sense of a diagnostic study for a specific condition.

8. The Sample Size for the Training Set

The document describes the submission as updates to an existing MRI system and the introduction of a DWI technique. It does not refer to an AI/ML model that requires a "training set" in the conventional sense. Therefore, information on a training set size is not applicable/not provided.

9. How the Ground Truth for the Training Set was Established

As there is no mention of an AI/ML algorithm or training set, this information is not applicable/not provided. The "HASTE readout sequence" mentioned for DWI is a specific MR imaging pulse sequence, not a machine learning algorithm.

Summary

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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.

ASG Superconductors S.p.A. % Luisella De Benedetti Quality and Regulatory Affairs Corso Ferdinando Maria Perrone 73/R Genova, 16152 ITALY

Re: K190524

Trade/Device Name: MRopen 0.5 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: May 14, 2019 Received: May 31, 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

July 1, 2019

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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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6. Statement of Indications for Use (form 3881)

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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)	K190524
	K190524
Device Name	MRopen 0.5 T

Indications for Use (Describe)

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)
-------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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."

FORM FDA 3881 (7/17)

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7. 510(k) Summary (21 CFR 807.92)

Date: (month/day/year) 05/14/2019

807.92(a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;

Submitter Information

Name	ASG Superconductors S.p.A.
Address	Corso Perrone 73R - 16152 Genova, Italy
Telephone n.	+39 010 6489 358
Contact Person	Luisella De BenedettiASG Superconductors S.p.A.Corso F.M. Perrone 73R16152 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 0.5 T
Trade name	ASG Superconductors
Classification name	Total Body Magnetic Resonance DiagnosticDevice
Classification and class of device	21 CFR 892.1000, class II
Classification Number	90LNH

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

PRIMARY PREDICATE (for all items excluded the below specified) Paramed S.r.1 Mr Open K151466 SECONDARY PREDICATE (FOR DWI-HASTE APPLICATION) K082331 Siemens Magnetom C! SECONDARY PREDICATE (FOR Compressors) AVANTO K032428 Siemens SECONDARY PREDICATE (FOR Spectrometer and shoulder coil) K122034 Paramed S.r.l MrJ 3300

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 K151466 cleared device.

Introduce DWI technique based on HASTE readout sequence 0
Introduce internally developed User Interface 0
Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA
0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
Long Spine receiving coil o
0 Shoulder coil new model
Changes to patient support shapes and courtesy cushions o

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

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ClaimedFeature	Discussion
Introduce DWItechniquebased onHASTEreadoutsequence	This sequence has been introduced to complete the sequence package ofthe MRopen 0.5 T tomograph, now that the updated hardware andsoftware grant better image quality results. Here the referred predicateis Siemens Magnetom C! K082331 Bibliography is supplied regardingthis well-known technique
IntroduceinternallydevelopedUser Interface	After many years of development it is possible to release this userinterface which is completely internally designed and excludes legacysoftware or software developed prior to IEC62304.
Introduce changes in hardware such as:
spectrometer	This spectrometer already employed for smaller tomograph ASGSuperconductors S.p.A. K122034 grants more flexibility to the newsoftware granting DWI technique performance
Compressorsand cold heads	We intend to adopt as an alternative (to Leybold ones) for servicing andfor newly designed device the Sumitomo F70H compressor modelsalready in use with Siemens AVANTO K0322428 predicate. CH-210Cold Head are indicated to be used together with F70H compressors.Both compressors and Cold Heads are declared conformant to IEC60601-1 by Sumitomo
RFA	We intend to adopt as an alternative (to Analogic Corp.) for servicingand for newly designed devices the RFT RF9200 9KW model
Introducechange inhardwareinside themagnet(double currentsame magneticfield)	ASG superconductors decided to double the current inside the magnetwhile keeping unchanged the magnetic field to reduce the number ofsuperconductive coils inside the vacuum chambers and this results in acost reduction due to less MgB2 wire.No change in material which is the same MgB2 manufactured within ASG Superconductors S.p.A. Columbus Wire Business Unit No change in supplier manufacturing process Completely owned proprietary magnet construction process
Long Spinereceiving coil	This receiving coil is equivalent to standard Spine coil in K151466designed to fit a longer column segment. It allows performing exams onadjacent sections of the spine without moving the coil under the patient

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Shoulder coil	This new model is derived from MrJ 3300 predicate device K122034and it will be employed together with the new patient comfortaccessories supplied
Patient comfortaccessories	back, but just adjusting patient table position inside the magnetisocenter.
	Some new cushion shapes and supports have been studied to improvecomfort during shoulder and head exams (no new materials andtechnologies)

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 0.5 T product is a Magnetic Resonance Diagnostic Device

MRopen 0.5 T is Total Body MRDD with the following limitation: no cardiac imaging, no breast imaging.

MRopen 0.5 T 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.

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

Intended population is for Patients less than 200 Kg

The new MRopen 0.5 T Tomograph can perform DWI images based on a Diffusion excitation pattern applied on a specific acquisition sequence, in this case the HASTE

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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.

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 0.5 T MRI system is substantially equivalent to

General item	MRopen 0.5 T	Primary PredicateK151466MrOpen	Secondary PredicateSiemens MagnetomC! K082331
Anatomical regions	Total body withthe followinglimitation: nocardiacimaging, nobreast imaging.	Total body with thefollowing limitation:no cardiac imaging,no breast imaging.	Total Body
Nucleus excited	Proton (hydrogen nucleus)
Diagnostic uses	Magnetic Resonance Diagnostic Device
SCOUT Multiplanar	Yes	Yes
Ortogonal (SE ο GFE)
Spin echo T1 (SET1)	Yes	Yes
Spin echo T2 (SET2)	Yes	Yes
Short TE spin echo(ERASE)	Yes	Yes
Double echo (DE)	Yes	Yes
Inversion recovery (IR)
Short TAU inversionrecovery (STIR)	Yes	Yes
General item	MRopen 0.5 T	Primary PredicateK151466MrOpen	Secondary PredicateSiemens MagnetomC! K082331
Short time inversionrecovery gradient fieldecho (GFE-STIR)	Yes	Yes
Gradient Field Echo(GFE)	Yes	Yes
Gradient Field Echo 3D(3D-GFE)	Yes	Yes
RF spoiled gradientecho 3D (3D-SPGFE)	Yes	Yes
Time reversed 3Dgradient Field Echo(3D-EMIT)	Yes	Yes
Rapid Imaging SE T2(RISE)	Yes	Yes
Rapid Imaging DE(RIDE)	Yes	Yes
Fast Inversion Recovery(FIR)	Yes	Yes
FLAIR - Fluidattenuated InversionRecovery	Yes	Yes
Spin Echo Presat -FAST RISE9 PRESAT	Yes	Yes
Fast Rise (up to 16echoes)	Yes	Yes
Fast PD (Fast protondensity)	Yes	Yes
3D Gradient BalancedSteady State (3D-GBASS)	Yes	Yes
Fat-Water separation T1(FWS T1)	Yes	Yes
ANGIO sequences	Yes	Yes
General item	MRopen 0.5 T	Primary Predicate	Secondary Predicate
		K151466MrOpen	Siemens MagnetomC! K082331
HASTE sequence	Yes	No	Yes
DWI technique	Yes	No	Yes
General item	MRopen 0.5 T	Primary	Predicate	K151466
		MrOpen
Magnetic system	•	High homogeneity Open-sky Magnet, based on high temperaturecryogenless superconductive, horizontal field
	Maximum Magnetic field 0.5 Tesla
	Current 146A	Current 84 A
	28000 kg
	200x200x170 cm (HxDxW)
	4.0 x 4.6 x 3.6 m (Vertical x Transversal x Longitudinal)
	<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		Analogic model AN8102

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General item	MRopen 0.5 T	Secondary Predicate K122034 MrJ
		3300
Spectrometer		ACS MRIBox

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ReceivingCoils' list	Code#autom.Recogn. digit	MRopen 0.5 T	PrimaryPredicateK151466MrOpen	SecondaryPredicateK122034 MrJ3300
C-Spine	03-2003 #7	✓	✓
Shoulder	03-2005 #9	✓	✓
Hand	03-2006 #4	✓	✓
MP-Loop	03-2010 #8	✓	✓
Flex S	03-2011 #12	✓	✓
Flex L	03-2012 #13	✓	✓
MP_Flat	03-2015 #14	✓	✓
Body	03-2019 #2	✓	✓
Knee	03-2018#3	✓	✓
Head	03-2001#1	✓	✓
Head/Neck	03-2020#10	✓	✓
Spine	03-2016#8	✓	✓
Long Spine	03-2100#11	✓	longer versionof 03-2016#8
Shoulder	03-2101#9	✓		✓

(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;

The MRopen 0.5 T has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and image quality and has been found to conform to the following medical device safety standards (see also Section 8 Conformance to Consensus Standards and test reports).

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According to our quality management system a report is issued if a standard changes, if the device changes or both. Not all the tests were newly performed where the above conditions did not apply

Standard	FDARecog.number	Rationale forrepeating tests	510(k) ref
IEC 60601-1	19-4	Hardware/Software changes Testrepeated	See belowsection 8
60601-2-33 Ed. 3.2b:2015	12-295	Standard Changed Test repeated	See belowsection 8
60601-1-2 Edition4.0 2014-02	19-8	Hardware changes Test repeated	See belowsection 8
60601-1-6 Edition3.1 2013-10	5-89	Software/Hardware changes Testrepeated	See belowsection 8
62366-1 Edition1.0 2015-02	5-114	Software changes Test repeated	See belowsection 8
62304 Edition 1.12015-06CONSOLIDATEDVERSION	13-79	Software changes Test repeated	See belowsection 8
62471 First edition2006-07	12-249	No change - Not repeated	K151466
MS-1-2008(R2014)	12-188	No change - Not repeated	K151466
MS 2-2008(R2014)	12-19	The standard NEMA MS-2 2008(R2014) changed introducing therequirement of using a squarevoxel for the test image. Wealready fullfilled that requirementand do not need to repeat the test	K151466
MS 3-2008(R2014)	12-187	No change - Not repeated	K151466
NEMA MS-4	12-232	No change - Not repeated	K151466
NEMA MS-5	12-231	No change - Not repeated	K151466

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MS(R2014)	6-2008	12-195	New Long Spine coil Test repeated	See belowsection 8
MS 8-2016		12-315	The Standard NEMA MS-8 2016 differ from the version used for previous 510(k) submission. As stated in the Introduction at pag. v, the modification aim to consider the method adjustement required by higher frequency transmitting coil (125 MHz) used in 3T systems. As the proposed equipment works at a much lower frequency (21 MHz) we evaluate to not repeat the connected test	K151466
MS(R2014)	9-2008	12-288	New Long Spine coil Test repeated	See belowsection 8
MS 10-2010		12-298	No change - Not repeated	K151466
NEMA PS 3.1		12-300	Software Changed	SeeAppendix H

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

No clinical tests were performed.

We supply images of healthy volunteers who agreed to cooperate to demonstrate performance of the device on humans.

A732/278

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Only main changes were tested:

Item tested	Result/remarks
New DWI technique base onHASTE readoutsequence	The images on healthy volunteers conform to theexpected image quality. Both ADC calculated imageand DWI images along the three main directions aredisplayed
New Long Spine coil	The use of this new receiving coil has been referredto the previous spine model for equivalent or betterquality image, with the workflow improvement of notnew coil positioning in case of multiple scan ofdifferent streches of spine. Performance test report inSection 18
Shoulder coil New model	This design is exactly the same employed in MrJ 3300secondary predicate device which better fits the newpatient comfort accessories during shoulder exam.Performance test report in Section 18

Population (healthy volunteers)

The healthy volunteers were adult male and female aged between 20 and 60 available in our firm.

(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.

The non clinical (bench) and clinical (healthy volunteers) data demonstrate MRopen 0.5T to be as safe, as effective and performs as well than the predicates. Mropen 0.5 T is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.

AM33/778

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.