SyMRI

GUDID 07340024700023

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems.

SyntheticMR AB (publ)

MRI system application software

• Primary Device ID: 07340024700023
• NIH Device Record Key: f814b30d-ea22-4e91-b1f9-de290104c42f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SyMRI
• Version Model Number: 10
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340024700023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162943

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-10

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