SyMRI

GUDID 07340024700078

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. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.

SyntheticMR AB (publ)

MRI system application software

• Primary Device ID: 07340024700078
• NIH Device Record Key: 6d84292b-e4c6-49f9-8701-82833f6cf8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SyMRI
• Version Model Number: 15
• Company DUNS: 775572188
• Company Name: SyntheticMR AB (publ)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340024700078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242524

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [SyMRI]

• 07340024700030: SyMRI is a post-processing software medical device intended for use in visualization of the brai
• 07340024700023: SyMRI is a post-processing software medical device intended for use in visualization of the brai
• 07340024700061: SyMRI is a post-processing software medical device intended for use in visualization of soft tis
• 07340024700078: SyMRI is a post-processing software medical device intended for use in visualization of soft tis