OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III

K091669 · Xioao Mdt Technology Co, Ltd. · LNH · Jun 18, 2009 · Radiology

Device Facts

• Record ID: K091669
• Device Name: OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
• Applicant: Xioao Mdt Technology Co, Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Open Magnetic Resonance Imaging System, MPF3000-III 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 MR system produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR 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 (E) and flow.

Device Story

0.3T permanent magnet MRI system; inputs include proton density, spin-lattice relaxation (T1), spin-spin relaxation (T2), and flow signals. System components: magnet, magnet enclosure, patient table, gradient coil, RF transmission/receiver coils, client PC, and imaging cabinet. Operates via PROSPECT software on Windows XP Professional. Used in clinical settings by physicians to visualize internal structures of head, body, or extremities. Output consists of transverse, coronal, sagittal, and oblique images. Provides non-invasive diagnostic information without ionizing radiation to assist clinical decision-making.

Clinical Evidence

Bench testing only. Performance testing validated that the device met all design specifications and complied with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and NEMA MS 1, MS 2, MS 3, MS 5, and MS 6 standards.

Technological Characteristics

0.3T permanent magnet MRI system. Components: magnet, magnet enclosure, patient table, gradient coil, RF transmission/receiver coils, client PC. Software: PROSPECT (Windows XP). Standards: IEC 60601-1:1988+A1:1991+A2:1995, IEC 60601-1-1:2000, IEC 60601-1-2:2001+A1:2004, NEMA MS 1-2001, NEMA MS 2-2003, NEMA MS 3-2003, NEMA MS 5-2003, NEMA MS 6-1991.

Indications for Use

Indicated for patients requiring non-invasive diagnostic imaging of the head, body, or extremities to obtain physiological and clinical information via proton density, T1, T2, and flow-based magnetic resonance imaging.

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

• mStar MPF4500 (K073457)

Submission Summary (Full Text)

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## 18 2009 JUN

Image /page/0/Picture/2 description: The image shows a logo with a stylized dolphin and text. The dolphin is facing left and appears to be leaping. To the right of the dolphin is the text "新奥博为" in Chinese characters, followed by "XinAo MDT" in English. The text is smaller than the dolphin image.

Exhibit #3 510(k) Summary

This 510/k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807 .92

Date of Submission: April 13, 2009

Sponsor :

11. Apr 11 13, 2009

JSQI.

XinAoMDT Technology Co., Ltd.

Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road(S)

Open Magnetic Resonance Imaging System, MPF3000-III

System, Nuclear Magnetic Resonance Imaging

No. 2, Huaxiang Road, Econ. & Tech. Development Zone, Langfang, Hebei, 065001, China. Contact Person: Ms. Guo Jinhong

T: [phone]

Ms. Diana Hong / Mr. Lee Fu

Shanghai, 200030, China

Class II, LNH, 892.1000

mStar MPF4500 (K073457)

F: [phone]

Correspondent :

Proposed Device Common Name: Classification: Predicate Device: Intended Use:

Open Magnetic Resonance Imaging System, MPF3000-III 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 MR system

produces transverse, coronal, sagittal and oblique images that display the internal structure of the head, body or extremities. The images produced by the MR 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 (E) and flow.

Device Description: Open Magnetic Resonance Imaging System, MPF3000-III is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Ciient PC, and Imaging Cabinet. The system software, PROSPECT, based on Windows XP® Professional is aninteractive program with user friendly interface.

Testing Conclusion: Performance testing was conducted to validate and verify that the proposed device, Open Magnetic Resonance Imaging System, MPF3000-III met all design specifications and was substantially equivalent to the predicate device. The proposed device complies with the following standards: IEC 60601-1:1988+A1:1991+A2:1995 / IEC 60601-1-1:2000 / IEC 60601-1-2:2001+A1:2004 / NEW MS-1-2001 / NEWA MS 2-2003 / NEMA MS 3-2003 / NEMA MS 5-2003 / NEMA MS 6-1991

SE Conclusion:

Open Magnetic Resonance Imaging System, MPF3000-HII, is claimed to be Substantially Equivalent (SE) to the predicate device, mStar MPF4500 (K073457)

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2009 JUL

XioAo MDT Technology Co., Ltd. % Mr Ned Devine Senior Staff Engineer. Program Reviewer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062-2096

Re: K091669

Trade/Device Name: Open Magnetic Resonance Imaging System, MPF3000-III Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: June 3, 2009 Received: June 9, 2009

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of June 18, 2009.

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 (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 vour 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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ioru Mr Whay

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows a black and white drawing of a dolphin. The dolphin is facing left and has a sleek body with a dorsal fin. To the right of the dolphin, there is text that reads "XinAo MDT" in a stylized font. The text is arranged in two lines, with "XinAo" on the top line and "MDT" on the bottom line.

Premarket Notification Section 510(k) Submission Ref No.: A2009-001-028 Section II Indication for Use

## Section II Indication for Use

1691669 510(k) Number: Device Name: Open Magnetic Resonance Imaging System, MPF3000-III

## Indications for Use:

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Prescription Use · · ﺗﮭﺎ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Aon Anhhang
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number KD91669

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