SyMRI - SyMRI is a post-processing software medical - SyntheticMR AB (publ)

Duns Number:775572188

Device Description: SyMRI is a post-processing software medical device intended for use in visualization of th

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More Product Details

Catalog Number

-

Brand Name

SyMRI

Version/Model Number

11

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173558,K181093,K191036,K201616

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

04c739fb-a81b-4ce5-9ffc-66796ca4f003

Public Version Date

August 05, 2020

Public Version Number

3

DI Record Publish Date

June 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHETICMR AB (PUBL)" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2