SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design. It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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. These images when interpreted by a trained physician, yield information that may assist in diagnosis. The MRI system is composed of magnet, RF Amplifier, Gradient Amplifier, RF Coils, control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP operating system is an interactive program with user friendly interface.

AI/ML Overview

The document describes the SuperVan 1.5T Magnetic Resonance Imaging System, which produces cross-section images of the internal structure of the whole body. The images reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance, and the NMR properties such as proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. These images, when interpreted by a trained physician, assist in diagnosis.

The study presented is to demonstrate that the proposed device, SuperVan 1.5T, is Substantially Equivalent (SE) to a predicate device, ACHIEVA 1.5T & INTERA 1.5T family (K052013), as per FDA requirements for 510(k) premarket notification. This type of submission focuses on comparing the proposed device to a legally marketed predicate device rather than on presenting de novo performance criteria with specific numerical targets.

Since it's a substantial equivalence submission for an MRI system, the "acceptance criteria" are primarily established through compliance with recognized international and national standards for medical electrical equipment and MR imaging performance, and direct comparison of technical specifications with the predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by conforming to existing standards and demonstrating similar technical characteristics to the predicate device. There are no specific numerical performance metrics (like sensitivity, specificity, accuracy) for disease detection or diagnosis provided in this summary. Instead, the performance is demonstrated by compliance with standards that ensure the device operates safely and produces images of sufficient quality for diagnostic purposes, comparable to the predicate device.

Item	Acceptance Criteria (Demonstrated by)	Reported Device Performance
Product Code	LNH (Same as predicate)	LNH
Regulation No.	21 CFR 892.1000 (Same as predicate)	21 CFR 892.1000
Class	Class II (Same as predicate)	Class II
Intended Use	Similar to predicate device (MRI system producing images for diagnosis by a trained physician)	SuperVan 1.5T Magnetic Resonance Imaging System produces transversal, sagittal and coronal and oblique cross-section images of internal body structure, reflecting proton density, T1, T2, and flow, to assist in diagnosis.
Installation Type	Fixed (Same as predicate)	Fixed
Magnet Type	Super-conducting (Same as predicate)	Super-conducting
Field Strength	1.5T (Same as predicate)	1.5T
Coil	Similar to predicate device	Head coil, neck coil, body coil, knee coil
Electrical Safety	Conforms to IEC 60601-1 and IEC 60601-2-33	Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-2-33:2002 + A1:2005 + A2:2007
EMC	Conforms to IEC 60601-1-2	Conforms to IEC 60601-1-2: 2007
Patient Contact Material	Similar to predicate	Synthetic resin, Acrylic acid lacquer
Biocompatibility	Conforms to ISO 10993 series standards	Conforms to the requirements of ISO 10993 series standards
Label and Labeling	Conforms to FDA Regulatory Requirements	Conforms to FDA Regulatory Requirements
Level of Concern of Software	Moderate (Same as predicate)	Moderate
Image Quality Parameters (SNR, Geometric Distortion, Uniformity, Slice Thickness, Acoustic Noise, SAR)	Conforms to NEMA MS standards	Conforms to NEMA MS 1, 2, 3, 4, 5, 6, 8 standards

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly mention a "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The non-clinical tests conducted relate to engineering specifications and compliance with standards. These tests typically involve phantoms and engineering measurements, not patient data for establishing a conventional "test set" like in AI/CADe device evaluations. The data provenance would be from laboratory testing and engineering measurements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission focuses on the technical and safety aspects of the MRI system itself, primarily through compliance with engineering standards and comparison with a predicate device. It does not involve a diagnostic performance study with a "ground truth" established by medical experts on a set of images for the device's diagnostic output. The "ground truth" for the device's output is expected to be interpreted by "trained physicians" in clinical use, which is mentioned in the intended use statement.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a diagnostic performance test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/CADe device. It is a Magnetic Resonance Imaging System, a hardware and software system used to acquire images. The study presented here is a substantial equivalence claim based on technical specifications and adherence to standards, not a comparative effectiveness study involving human readers and AI assistance for diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-only device. It is a complete MRI system.

7. The Type of Ground Truth Used

The ground truth here is established by compliance with recognized engineering and safety standards (IEC, ISO, NEMA) for medical devices and MRI systems. For image quality parameters (like SNR, geometric distortion, uniformity, etc.), the "ground truth" would be the specified values or ranges defined in these standards.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a machine learning algorithm that requires a "training set" of data for its diagnostic performance. The software mentioned (AnkeStation) is described as an "interactive program with user friendly interface" for controlling the MRI system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning algorithm described.

Summary

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KB1896
Page 1 of 8

Exhibit #3 510 (k) Summary

Project #: M0072013Ad

Exhibit #3 510(k) Summary.

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K131896

1. Date of Submission: 06/10/2013
Sponsor Identification 2.

Suzhou Anke Medical System Co., Ltd Building K, 128 Xingpu Road. Suzhou Industrial Park, Jiangsu. 215126, China

Establishment Registration Number: Not yet registered

Contact Person: Weijie Xia Position: Registration specialist Tel: +86-10-51530223 Fax: +86-512-62956068 Email: xiaweijie@ankemri.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.

Proposed Device Name: SuperVan 1.5T Magnetic Resonance Imaging System Proposed Device Common Name: Magnetic Resonance Imaging System

Regulatory Information: Classification Name: system. nuclear magnetic resonance imaging: Classification: II; Product Code: LNH ; Regulation Number: 21 CFR 892.1000; Review Panel: Radiology;

Intended Use Statement:

SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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 (12) and flow. These images when interpreted by a trained physician, vield information that may assist in diagnosis.

Predicate Device Identification 5.
510(k) Number: K052013 Product Name: ACHIEVA 1.5T & INTERA 1.5T family Manufacturer: Philips Medical Systems Nederland BV

Device Description 6.

The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design.

It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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 (172) and flow. These images when interpreted by a trained physician, vield information that may assist in diagnosis.

The MRI system is composed of magnet. RF Amplifier, Gradient Amplifier, RF Coils. control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP E3-2

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operating system is an interactive program with user friendly interface.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verily that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

IEC 60601-1-1:2000. Medical electrical equipment -- Part 1-1: General requirements for salety -Collateral standard: Safety requirements for medical electrical systems.

IEC 60601-2-33, Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. 2002; Amendment 1. 2005. Amendment 2, 2007.

IEC 60601-1-2: 2007. Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.

IEC 62366: 2007. Medical devices - Application of usability engineering to medical devices.

ISO 10993-1: 2009. Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,

150 10993-10:2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging.

NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images.

NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Resonance Images.

NEMA MS 4-2010. Acoustic Noise Measurement Procedure for Diagnosing Magnetic.

NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging.

NEMA MS 6-2008, Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging.

NEMA MS 8-2008, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems.

8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

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Item	Proposed Device	Predicate Device
Product Code	LNH	Same
Regulation No.	21 CFR 892.1000	Same
Class	Class II	Same
Intended Use	SuperVan 1.5T Magnetic Resonance Imaging Systemis a MRI system that produces transversal, sagittal andcoronal and oblique cross-section images of theinternal structure of the whole body. The imagesproduced by the SuperVan 1.5T system reflect thespatial distribution of protons (hydrogen nuclei)exhibiting magnetic resonance. The NMR propertiesthat determine the image appearance are protondensity, spin-lattice relaxation time (T1), spin-spinrelaxation time (T2) and flow. These images wheninterpreted by a trained physician, yield informationthat may assist in diagnosis.	Similar
Installation Type	Fixed	Same
Magnet Type	Super-conducting	Same
Field Strength	1.5T	Same
Coil	Head coil, neck coil, body coil, knee coil	Similar
Electrical Safety	Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995.IEC 60601-2-33:2002 + A1:2005 + A2:2007	Same
EMC	Conforms to IEC 60601-1-2: 2007	Same
Patient Contact	Synthetic resin	Similar
Material	Acrylic acid lacquer	Same
Biocompatibility	Conforms to the requirements of ISO 10993 seriesstandards	Same
Label and Labeling	Conforms to FDA Regulatory Requirements	Same
Level of Concern ofthe Software	Moderate	Same

Table 3-1 Comparison of Technology Characteristics

The proposed device and predicate devise share same classification and safety characteristics, similar intended use and technical specifications, the difference is too slight, will not affectiveness and safety of proposed device.

The proposed device. SuperVan 1.5T Magnetic Resonance Imaging System, is determined to be Substantially Equivalent (SE) to the predicate device, ACHIEVA 1.5T & INTERA 1.5T family (K052013). in respect of safety and effectiveness.

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Exhibit #3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectivencss information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __K131896

Date of Submission: 06/10/2013 1.
1. Sponsor Identification

Suzhou Anke Medical System Co., Ltd Building K. 128 Xingpu Road. Suzhou Industrial Park, Jiangsu. 215126, China

Establishment Registration Number: Not yet registered

Contact Person: Weijie Xia Position: Registration specialist Tel: +86-10-51530223 Fax: +86-512-62956068 Email: xiawcijic@ankemri.com

1. Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120. China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.
Proposed Device Name: SuperVan 1.5T Magnetic Resonance Imaging System Proposed Device Common Name: Magnetic Resonance Imaging System

Regulatory Information: Classification Name: system, nuclear magnetic resonance imaging; Classification: II: Product Code: LNH ; Regulation Number: 21 CFR 892.1000; Review Panel: Radiology;

Intended Use Statement:

SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T 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 (II), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician. yield information that may assist in diagnosis.

Predicate Device Identification 5.
510(k) Number: K052013 Product Name: ACHIEVA 1.5T & INTERA 1.5T family Manufacturer: Philips Medical Systems Nederland BV

Device Description 6.

The proposed device, SuperVan 1.5T, is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in an open gantry design.

It's indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.57 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 (11), spin-spin relaxation time (12) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The MRI system is composed of magnet. RF Amplifier. RF Coils. console, console, control computer, intercom system and water chiller. The system software, AnkeStation, based on Windows XP E3-2

{6}------------------------------------------------

operating system is an interactive program with user friendly interface.

Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.

IEC 60601-1-1:2000. Medical equipment -- Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems.

IEC 60601-2-33, Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic. 2002; Amendment 1. 2005, Amendment 2, 2007.

IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.

IEC 62366: 2007, Medical devices - Application of usability engineering to medical devices.

ISO 10993-1: 2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10:2010. Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

NEMA MS 1-2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging.

NEMA MS 2-2008, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images.

NEMA MS 3-2008, Determination of Image Uniformity in Diagnostic Resonance Images. NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic.

RDMRTRD 1-2018, Procedure Noise Measurement Procedure for Diagnosing Magnetics.

NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Resonance Imaging.

NEMA MS 6-2008, Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging,

NEMA MS 8-2008, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems.

8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

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Item	Proposed Device	Predicate Device
Product Code	LNH	Same
Regulation No.	21 CFR 892.1000	Same
Class	Class II	Same
Intended Use	SuperVan 1.5T Magnetic Resonance Imaging Systemis a MRI system that produces transversal, sagittal andcoronal and oblique cross-section images of theinternal structure of the whole body. The imagesproduced by the SuperVan 1.5T system reflect thespatial distribution of protons (hydrogen nuclei)exhibiting magnetic resonance. The NMR propertiesthat determine the image appearance are protondensity, spin-lattice relaxation time (T1), spin-spinrelaxation time (T2) and flow. These images wheninterpreted by a trained physician, yield informationthat may assist in diagnosis.	Similar
Installation Type	Fixed	Same
Magnet Type	Super-conducting	Same
Field Strength	1.5T	Same
Coil	Head coil, neck coil, body coil, knee coil	Similar
Electrical Safety	Conforms to IEC 60601-1:1988 + A1:1991 + A2:1995.IEC 60601-2-33:2002 + A1:2005 + A2:2007	Same
EMC	Conforms to IEC 60601-1-2: 2007	Same
Patient Contact	Synthetic resin	Similar
Material	Acrylic acid lacquer	Same
Biocompatibility	Conforms to the requirements of ISO 10993 seriesstandards	Same
Label and Labeling	Conforms to FDA Regulatory Requirements.	Same
Level of Concern ofthe Software	Moderate	Same

Table 3-1 Comparison of Technology Characteristics

The proposed device and predicate devise share classification and safety characteristics, similar intended use and technical specifications, the difference is too slight, will not affectiveness and safety of proposed device.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2014

Suzhou Anke Medical Systems Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. BOX 120-119 SHANGHAI 200120 CHINA

Re: K131896

Trade/Device Name: Supervan 1.5T Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 27, 2014 Received: January 31, 2014

Dear Ms. Hong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); 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.

{9}------------------------------------------------

Page 2-Ms. Hong

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its internet address

htm//www.fda.gov/MedicalDevices/ResourcesforYou/industry/default.htm. 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/Reportal?roblem/default.html 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 (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.html

Sincerely yours.

William D. Hara

for

Janine M: Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{10}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131896

Device Name

SuperVan 1.5T Magnetic Resonance Imaging System

Indications for Use (Describe)

SuperVan 1.57 Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the images produced by the SuperVan 1.5T1 system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Michael D. O'Hara

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Regulation Number and Section

§ 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.