MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035

K061132 · Neusoft Medical Systems Co., Ltd. · LNH · May 24, 2006 · Radiology

Device Facts

• Record ID: K061132
• Device Name: MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
• Applicant: Neusoft Medical Systems Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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.

Device Story

Superopen 0.35T is a 0.35T permanent magnet MRI system; magnet constructed from NdFeB material. Device utilizes gradient subsystem for uniform magnetic fields in X, Y, Z planes; RF subsystem for signal transmission/reception. System captures proton density, T1, T2, and flow data; processes signals to generate 2D/3D cross-sectional images. Operated by trained physicians/technicians in clinical settings. Console computer with Windows-based interactive interface controls scanning, image reconstruction, and archiving. Output images displayed for physician interpretation to assist in clinical diagnosis. Benefits include non-invasive visualization of internal anatomy without ionizing radiation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing of the MRI system components.

Technological Characteristics

0.35T permanent magnet MRI system; NdFeB magnet material. Gradient subsystem for X, Y, Z field control; RF subsystem for signal processing. Supports 2D/3D imaging (SE, STIR, FLAIR, FE, FESP, FESS-FID, FSE, MRCP, TOF, MTC, EPI). DICOM 3.0 compliant. Standards: IEC60601-1, IEC60601-2-33, IEC60825-1, NEMA MS1-MS8.

Indications for Use

Indicated for patients requiring non-invasive diagnostic imaging of the head, body, spine, and extremities. Supports proton density, T1, T2, and diffusion-weighted imaging, as well as MR angiography. Used for diagnostic visualization of internal structures.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Superopen 0.35T (K030918)

Submission Summary (Full Text)

{0}------------------------------------------------

Neusoft

Image /page/0/Picture/1 description: The image shows the text "Kob 11/32" in a handwritten style. The text is written in black ink on a white background. The letters and numbers are slightly slanted to the right.

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 892.1000<br>Magnetic 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: General<br>Requirements for Safety<br>IEC60601-2-33, Medical electrical equipment - Part 2-33: Particular<br>requirements for the safety of magnetic resonance equipment for<br>medical diagnosis<br>21 CFR Subchapter J, Radiological Health<br>IEC60825-1, Safety of laser products-Part1:Equipment classification,<br>requirement and user's guide<br>DICOM 3.0<br>NEMA MS Series (MS1 - MS8) |
| Manufacture: | Philips and neusoft medical systems Co.,Ltd.<br>Neusoft Park, Hun Nan Industrial Area, Shenyang 110179. China |
| Distributor: | Neusoft Medical Systems Co., Ltd.<br>No.3-11, Wenhua Road, Heping District, Shenyang, 110004, China |
| Submitter: | Contact : Tian Yanfang<br>Title : Manager of Quality Management Department<br>Tel : [phone]<br>Fax : [phone]<br>E-Mail : [e-mail]<br>Summary prepared : April 18, 2006 |

{1}------------------------------------------------

# Neusoft

Page 2 of 2

#### Safety and Effectiveness information

Intended Uses:

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.

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.

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.

{2}------------------------------------------------

### 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**

{3}------------------------------------------------

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 [phone] or [phone] 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

{4}------------------------------------------------

# Neusoft

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 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

(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)