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510(k) Data Aggregation
K Number
K233733Device Name
SyMRI
Manufacturer
SyntheticMR AB (Publ)
Date Cleared
2024-03-26
(126 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
SyntheticMR AB (Publ)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD)
SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI.
When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging.
SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence.
When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
Device Description
SyntheticMR's SyMRI is a Class II Magnetic resonance diagnostic device (Requlation # 892.1000) with product code LNH. The device has no components and/or accessories.
SyMRI works by post-processing a multi-delay, multi-echo acquisition into parametric maps. The acquisition is either a multi-slice 2D approach (M2D-MDME), consisting of 4 delays with a short and a long echo time each (8 images per slice), or a 3D approach (3D-QALAS) consisting of 4 delays with a short echo and 1 delay with a long echo time (5 images per slice).
The parametric maps are R1, R2 relaxation rates, and proton density (PD). The inverse relaxation parameters, T1 relaxation time (1/R1), and T2 relaxation time (1/R2) are also provided as parametric maps.
SyMRI enables the users to obtain volumetric information in the head, including white matter (WM), grey matter (GM), cerebrospinal fluid (CSF), Myelin correlated (MyC) partial volume, brain parenchyma (BP) and intracranial cavity (IC). This is accomplished by using tissue definitions based on the parametric maps. The tissue definitions provide tissue partial volume, or tissue fraction, per voxel. SyMRI also provides image processing tools to extract the values of the parametric maps, and tissue partial volume, per individual voxel, per region of interest, or the entire imaging volume.
The parametric maps can also be visualized as contrast weighted MR images, such as T1, T2, PD, and Inversion Recovery (IR) weighted images (including T1-FLAIR, T2-FLAIR, STIR, Double IR, and PSIR weighted images). SyMRI calculates the pixel signal intensity as a function of R1, R2, PD, and desired MR scanner settings, such as echo time (TE), repetition time (TR), and inversion delay time (TI). A number of default settings for TE, TR, and TI are provided, but the user has the ability to change the contrast of the images.
SyMRI generates all the different image contrasts from the same parametric maps, derived from the same acquisition. This leads to enhanced image slice registration, owing to the absence of interacquisition patient movement. SyMRI provides the user the ability to change the contrast of the images after the acquisition. This is performed by adjusting the TE, TR, and/or TI parameters postacquisition, to generate the specific contrast desired.
SyMRI is intended to be used to process data produced by any of the following acquisition sequences:
- M2D-MDME sequence data from GE MAGiC ●
- M2D-MDME sequence data from Philips SyntAc
- . M2D-MDME sequence data from Siemens TSE MDME
- 3D-QALAS sequence data from Philips 3DSyntAc Only 3T .
SyMRI can also create contrast weighted images from 3D-QALAS but these are only available in the product for quality assurance purposes as a risk mitigation related artifacts that could affect quantification and segmentation, and should not be used for clinical purposes.
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