(9 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard MRI components and software.
No
The device is described as an "imaging device" intended to provide "physiological and clinical information" and produce "images" of internal structures, which are all diagnostic functions, not therapeutic ones.
Yes
Magnetic Resonance Imaging (MRI) systems are used to produce images that display the internal structure of the body, providing physiological and clinical information to physicians, which aids in diagnosis.
No
The device description explicitly lists multiple hardware components (Magnet, Patient Table, Gradient Coil, RF Coils, Client PC, Imaging Cabinet) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "imaging device" used to obtain "physiological and clinical information" non-invasively. It produces images of internal structures.
- Device Description: The description details the components of an MRI system, which is an imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease or condition based on the analysis of such samples. IVDs are typically used in laboratories or point-of-care settings to perform tests on biological specimens.
This device is a medical imaging system used for diagnostic purposes, but it operates by capturing images of the body directly, not by analyzing samples taken from the body.
N/A
Intended Use / Indications for 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.
Product codes
LNH
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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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 :
- 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: +86 0316 2596056
Ms. Diana Hong / Mr. Lee Fu
Shanghai, 200030, China
Class II, LNH, 892.1000
mStar MPF4500 (K073457)
F: +86 0316 2596089
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
2
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 (800) 638-2041 or (240) 276-3150 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:
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 imogen that display the internet the MR system produces transvelse, coronal, sagittal and obligue 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.
Prescription Use · · ﺗﮭﺎ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE on another Page of NEEDED) a
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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