SUPEROPEN 0.23T, MODEL NAM-P023A

K033315 · Neusoft Digital Medical Systems Co., Ltd. · LNH · Oct 29, 2003 · Radiology

Device Facts

• Record ID: K033315
• Device Name: SUPEROPEN 0.23T, MODEL NAM-P023A
• Applicant: Neusoft Digital Medical Systems Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Superopen 0.23T 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 0.23T is a 0.23T permanent magnet MRI system; magnet constructed of NdFeB material. Device captures proton magnetic resonance signals; transforms inputs via gradient subsystems and RF subsystems into 2D/3D cross-sectional images (transverse, coronal, sagittal, oblique, curved). Operated by trained clinicians in clinical settings. System software (Windows-based) manages scanning control, image reconstruction, and archiving. Physician interprets images to assess internal structures of head, body, spine, and extremities; aids in clinical diagnosis. Benefits include non-invasive visualization without ionizing radiation.

Clinical Evidence

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

Technological Characteristics

0.23T permanent magnet MRI system; magnet material: NdFeB. Components: Gradient subsystem (X, Y, Z planes), RF subsystem (transmitting/receiving/processing). Connectivity: DICOM 3.0 compliant. Standards: IEC60601-1, IEC60601-2-33, IEC60825-1, NEMA MS Series (MS1-MS8). Software: Windows-based interactive program for scan control, reconstruction, and archiving.

Indications for Use

Indicated for imaging of head, body, spine, and extremities in patients requiring non-invasive diagnostic visualization. Supports T1, T2, proton density weighted imaging, and MR Angiography using 2D/3D sequences.

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 (MRI System) (K030918)

Submission Summary (Full Text)

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## Attachment 1

KO 33315

# 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:

.

| Trade Name: | Superopen 0.23T |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model: | NAM-P023A (MRI System) |
| 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 and<br>Distributor: | NEUSOFT Digital Medical Systems Co., Ltd.<br>No.3-11,Wenhua Road, Heping District,<br>Shenyang, P.R.China<br>Post Code : 110004 |
| Submitter: | Contact : Wang Zhiqiang<br>Title : Manager of Quality Management Department<br>Tel : [phone]<br>Fax : [phone]<br>E-Mail : [e-mail]<br>Summary prepared : July 16th, 2003 |

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510(k)

Page 2 of 2

#### Safety and Effectiveness information

Intended Uses:

The Superopen 0.23T 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 0.23T is a 0.23T 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 (MRI System)

Statement of Substantial Equivalence:

The Superopen 0.23T is of comparable type and substantially equivalent to the NEUSOFT Superopen 0.35T (K030918) in that they are similar in technology and intended uses. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Neusoft Digital Medical Systems Co., Ltd. % Mr. Heinz-Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

#### Re: K033315

Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 13, 2003

Received: October 15, 2003

Dear Mr. Steneberg:

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

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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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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**NEUSOFT**

510(k)

Attachment 2 Page 2 of 2

KO333315 510(k) Number (if Known) Device Name: Superopen 0.23T Indications for use:

The Superopen 0.23T 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 |
| Diagnostic uses: | T1, T2, proton density 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 |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use*

David A. Seaman

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