(13 days)
K103330, GE 1.5T Brivo MR355/Optima MR360
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No
The document describes standard MRI technology and image processing techniques without mentioning AI or ML.
No
The device is described as a "diagnostic imaging device" used to "assist in diagnosis," not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states: "It is indicated for use as a diagnostic imaging device... The images produced by the Brivo MR355... when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly details hardware components such as superconducting magnets, gradients, radio frequency coils, and electronics, indicating it is a physical medical device, not software-only.
Based on the provided information, the Brivo MR355 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "diagnostic imaging device" that produces images and/or spectra. These are interpreted by a trained physician to assist in diagnosis. IVD devices, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a magnetic resonance scanner that uses physical principles (magnetic fields and RF transmissions) to acquire data from the entire body. This is a direct imaging technique performed in vivo (within the body).
- Lack of Mention of Specimens: There is no mention of the device being used to analyze biological specimens.
Therefore, the Brivo MR355 falls under the category of an in vivo diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
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.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K103330, GE 1.5T Brivo MR355/Optima MR360
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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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 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
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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:
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.
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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