The Superopen 0.35T(Modified) is intended to produce images that reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The Superopen 0.35T(Modified) is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton T1.T2, proton density weighted imaging
Diagnostic uses: Diffusion weighted imaging MR Angiography Imaging processing
Imaging capabilities: 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D,3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS)
2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP
MR Angiography 2D, 3D TOF
MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion

Device Description

The Superopen 0.35T(Modified) is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

AI/ML Overview

This is a 510(k) premarket notification for a Class II medical device, specifically a Magnetic Resonance (MR) diagnostic device. The provided text is mostly administrative and does not contain specific study details or acceptance criteria for device performance in the way a clinical trial or performance study report would.

Therefore, most of the requested information cannot be extracted from this document, except for the "acceptance criteria" which, in this context, refers to the general functional specifications and intended use of the MRI system, and the device's reported performance as a substantially equivalent device.

Here's what can be extracted and what cannot:

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

Category / Criteria	Acceptance Criteria (Implied by Intended Use)	Reported Device Performance (Summary of Substantial Equivalence)
Intended Use	Produce images reflecting spatial distribution of protons (hydrogen nuclei). Provide diagnostic information when interpreted by a trained physician.	The Superopen 0.35T (Modified) is intended to produce images that reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information useful in determining a diagnosis.
Imaging Capabilities	Image various anatomical regions (Head, Body, Spine, Extremities). Excite Proton nuclei. Perform T1, T2, proton density weighted imaging, Diffusion-weighted imaging, MR Angiography. Incorporate 2D, 3D imaging, Spin Echo (SE), Short time inversion recovery (STIR), Fluid attenuated inversion recovery (FLAIR), Field Echo (FE), Field Echo with Spoiler (FESP), Fast Spin Echo (FSE), MRCP, TOF, MTC Echo Planar Imaging (EPI), Multi-shot SE/FE Diffusion.	Same as the Intended Use; the device performs these imaging capabilities.
Technology	Open-permanent-magnet MR Imaging System. Uses Gradient Subsystem. Uses RF Subsystem. Console computer with interactive user interface for image reconstruction and management. Produces 2D and 3D images.	The Superopen 0.35T (Modified) is a 0.35T permanent magnet MRI system. It is of comparable type and substantially equivalent to the predicate device (Superopen 0.35T, K030918), sharing similar technology and intended uses. Both use Gradient and RF Subsystems and a console computer for image reconstruction, producing 2D and 3D images.

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

Not provided. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific test sets.

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)

Not provided. No information on specific test sets or ground truth establishment is included. The document notes that "interpreted by a trained physician, these images provide information that can be useful in diagnosis determination," but this refers to the general clinical use of MRI, not a specific ground truth for a performance study.

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

Not provided. No information on test set adjudication.

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

Not applicable / Not provided. This document describes an MRI hardware system, not an AI-powered diagnostic software or a system requiring human readers to interpret its output for an MRMC study comparing AI-assisted vs. unassisted performance. The device itself is a diagnostic imaging tool.

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

Not applicable / Not provided. This refers to an MRI hardware system, not an algorithm that would be evaluated in a standalone performance study.

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

Not provided. No information on ground truth for any specific performance study is included. The device's substantial equivalence is based on its similarity to a predicate MRI machine.

8. The sample size for the training set

Not applicable / Not provided. This document is not describing a machine learning algorithm that would have a training set. It refers to an MRI system.

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

Not applicable / Not provided. As above, no training set is relevant to this document.

Summary

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510(k)

Attachment 1

MAY 2 4 2006

Summary of Safety and Effectiveness

Page 1 of 2

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

General Information:

Product Name:	Superopen 0.35T
Product Model:	NSM-P035
CFR Section:	21 CFR Part 892.1000Magnetic resonance diagnostic device
Classification Name:	System, Magnetic Resonance Imaging
Product Code:	LNH
Device Class:	Class II
Applicable Standard:	IEC60601-1, Medical electrical equipment - Part 1: GeneralRequirements for SafetyIEC60601-2-33, Medical electrical equipment - Part 2-33: Particularrequirements for the safety of magnetic resonance equipment formedical diagnosis21 CFR Subchapter J, Radiological HealthIEC60825-1, Safety of laser products-Part1:Equipment classification,requirement and user's guideDICOM 3.0NEMA MS Series (MS1 - MS8)
Manufacture:	Philips and neusoft medical systems Co.,Ltd.Neusoft Park, Hun Nan Industrial Area, Shenyang 110179. China
Distributor:	Neusoft Medical Systems Co., Ltd.No.3-11, Wenhua Road, Heping District, Shenyang, 110004, China
Submitter:	Contact : Tian YanfangTitle : Manager of Quality Management DepartmentTel : 86-24-83660649Fax : 86-24-83780480E-Mail : Tianyanfang@neusoft.comSummary prepared : April 18, 2006

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Page 2 of 2

Safety and Effectiveness information

Intended Uses:

Device Description:

Predicated Device:

K030918 : Superopen 0.35T

Statement of Substantial Equivalence:

The Superopen 0.35T(Modified) is of comparable type and substantially equivalent to the Superopen 0.35T (K030918) in that they are similar in technology and intended uses. It is a modified product based on the Superopen 0.35T. Both of these systems are open-permanent-magnet MR Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z planes, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console's computer that has an interactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI unit.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 2 4 2006

Mr. Tian Yanfang Manager of Quality Management Department Neusoft Medical Systems Co., LTD No. 3-11, Wenhua Road, Heping District Shenyang, Liaoning, 110004 P.R. CHINA

Re: K061132

Trade/Device Name: Superopen 0.35T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 18, 2006 Received: April 24, 2006

Dear Mr. Yanfang

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a black and white logo for the FDA Centennial from 1906-2006. The logo is circular with text around the perimeter. The letters FDA are in the center of the logo in a bold font, with the word Centennial underneath. There are three stars below the word Centennial.

Protecting and Promoting Public Health

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology).	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k)

Page 2 of 2 Attachment 2

ィ

Kol 1132 510(k) Number (if Known)

Device Name: Superopen 0.35T Indications for use:

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1.T2, proton density weighted imaging Diagnostic uses: Diffusion weighted imaging MR Angiography Imaging processing Imaging capabilities: 2D, 3D Spin Echo( SE ) Short time inversion recovery (STIR) Fluid attenuated inversion recovery (FLAIR) 2D,3D Field Echo (FE) 2D, 3D Field Echo with Spoiler (FESP) 2D FESP Multi-Slice (FESP-MS)

2D and 3D Field Echo Steady State FID with rephasing gradient (FESS-FID) 2D, 3D Fast Spin Echo (FSE) 2D, 3D MRCP

MR Angiography 2D, 3D TOF

MTC Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segarra

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

N/A