MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A

{0}------------------------------------------------ Kobas60 ## Attachment 1 ### OCT 2 7 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 0.23T | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Model: | NAM-P023 A | | 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 Medical Systems Co., Ltd.<br>No.3-11, Wenhua Road, Heping District,<br>Shenyang, China<br>Post Code : 110004 | | Submitter: | Contact : Tianyanfang<br>Title : Manager of Q&R Department<br>Tel : 86-24-83660649<br>Fax : 86-24-83780480<br>E-Mail : Tianyanfang@neusoft.com<br>Summary prepared : August 15th, 2006 | {1}------------------------------------------------ #### Safety and Effectiveness information Intended Uses: The Superopen 0.23T(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 (T), 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(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: K033315 : Superopen 0.23T Statement of Substantial Equivalence: The Superopen 0.23T(Modified) is of comparable type and substantially equivalent to the Superopen 0.23T (K033315) in that they are similar in technology and intended uses. It is a modified product based on the Superopen 0.23T. 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}------------------------------------------------ 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 caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. Food and Drug Administration 9200 Cornorate Blvd. Rockville MD 20850 Mr. Tian Yanfang Manager of Quality Management Department Neusoft Medical System Co., Ltd No.3-11, Wenhua Road, Heping District Shenvang, Liaoning, 110004 R.P. CHINA OCT 2 7 2006 Re: K062860 Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 20, 2006 Received: September 25, 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 circular logo or emblem. The text "1886-1986" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars around the circle. *Protecting and Promoting Public Health* {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean i tease be actised a determination that your device complies with other requirements of the Act that I Dr. Head statutes and regulations administered by other Federal agencies. You must of any I vith 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 fordinal in the quant) byeveline (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) I mis letter will and in Jours substantial equivalence of your device of your device to a legally premailer nodicate 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 if you desire specifice at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Hogdon 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 2 510(k) Number (if Known) Device Name: Superopen 0.23T Indications for use: indications for use. The Superopen 0.23T(Modified) is an imaging device, and is intended to provide the physician with The bapt open olds it (1/2 and 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. KOL2860 The indications for use are as follows: | Anatomical Region: | Head, Body, Spine, Extremities | |-----------------------|------------------------------------------------------| | Nucleus excited: | Proton | | Diagnostic uses: | T1, T2, proton density weighted imaging | | | 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) David h. Leyman (Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number Prescription Use