The Brivo MR355 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Brivo MR355 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The modified Brivo MR355 adds (1) one dedicated coil: 4-ch Breast Array Coil: (2) two clinical applications: VIBRANT and 3D FIESTA-C. The coil and clinical applications are standard for predicate Optima MR360 (K103330). All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 features a superconducting magnet at 1:5 Tesla. The data acquisition system operating accommodates up to 8 independent receive channels in various increments, and multiple independent coil elements per channel The system uses a during a single acquisition series. combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The 1.5T Brivo MR355 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

The provided text focuses on the 510(k) Premarket Notification Submission for the GE 1.5T Brivo MR355 Magnetic Resonance Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document explicitly states:

"The subject of this premarket submission, GE 1.5T Brivo MR355, did not require clinical studies to support substantial equivalence."

Therefore, the submission does not contain information related to acceptance criteria or a study proving the device meets said criteria. The GE 1.5T Brivo MR355 achieved regulatory clearance based on demonstrating substantial equivalence to an existing predicate device (K103330, GE 1.5T Brivo MR355/Optima MR360) and compliance with medical standards through non-clinical tests (e.g., risk analysis, requirements reviews, design reviews, performance testing, safety testing, internal and external evaluation).

Because no clinical study was required or performed for this specific submission to demonstrate acceptance criteria, the following requested information cannot be provided from the given text:

A table of acceptance criteria and the reported device performance: Not applicable as no such study was conducted.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is an MR imaging device, not an AI-assisted diagnostic tool in the context of this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are black, and the background is white.

Device Description:

MAR 2 7 2012

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	October 17, 2011
Submitter:	GE Hangwei Medical Systems Co.,Ltd. No.2 Yong Chang North Road, Beijing Economic & Tech Development Area Beijing, 100176, P.R.China
Primary Contact Person:	Ruoqian Liu Regulatory Affairs Manager GE Hangwei Medical Systems Co.,Ltd. 86-10-58068943 (Tel) 86-10-67803267 (Fax) ruoqian.liu@med.ge.com
Secondary Contact Person:	Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) (262) 521-6848 (262) 894-4968 Glen.Sabin@med.ge.com
Establishment Registration Number:	9613445
Device Trade Name:	GE 1.5T Brivo MR355
Common/Usual Name:	Magnetic Resonance Imaging System
Classification	21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device
Names:Product Code:	LNH
Predicate Device(s):	K103330, GE 1.5T Brivo MR355/Optima MR360

The 1.5T Brivo MR355 features a superconducting magnet at 1:5 Tesla. The data acquisition system operating accommodates up to 8 independent receive channels in various increments, and multiple independent coil elements per channel The system uses a during a single acquisition series. combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and

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GE Healthcare

510(k) Premarket Notification Submission

position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The 1.5T Brivo MR355 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Intended Use:

Technology:

Determination of Substantial Equivalence:

GE 1.5T Brivo MR355 employs the same fundamental scientific technology as its predicate device.

Summary of Non-Clinical Tests:

GE 1.5T Brivo MR355 system is designed for compliance to the medical standards as detailed in the Section 9.1 and 18 of this. premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
Requirements Reviews ●
Design Reviews .
Performance Testing (Verification) .
Safety Testing (Verification) ●
� Internal and External Evaluation (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, GE 1.5T Brivo MR355, did not require clinical studies to support substantial equivalence. However, clinical images from validation have been included in Section 20 of this submission.

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<12077

Image /page/2/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The frame has a swirling pattern around the letters, giving it a distinctive and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

Conclusion: GE Healthcare considers the GE 1.5T Brivo MR355 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MAR 2 7 2012

Mr. Ruoquian Liu Regulatory Affairs Manager, MR Modality GE Hangwei Medical Systems Co., Ltd. No. 2 Yong Chang North Road, Beijing Economic & Tech Development Area 100176 BEIJING BEIJING CHINA

Re: K120778

Trade/Device Name: GE 1.5T Brivo MR355 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 29, 2011 Received: March 14, 2012

Dear Mr. Liu:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: GE 1.5T Brivo MR355

Indications for Use:

The Brivo MR355 is a whole body magnetic resonance scanner designed to support high The DITVO MIX35 10 a vo-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, thaghostic images, parametric maps, and/or spectra, dynamic images of the structures spectrosoople images, parameters, including, but not limited to, head, neck, TMJ, spine, and of Imetions of the pelvis, joints, prostate, blood vessels, and musculoskeletal breast, ficar, abdoment, perms, yound, pregion of interest being imaged, contrast agents regions of the body. Deponding on any the Brivo MR355 reflect the spatial distribution or may or asses. The mironment of nuclei exhibiting magnetic resonance. These images and/or moredular on received by a trained physician yield information that may assist in diagnosis.

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Conguirence of OPRH, Office of In Vitro Diagnostic Devices (OIVD)

Humphrey Hawkins

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k)

Page 1 of

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.