Catalog Number

SMNS0001

Brand Name

MRIaudio Siemens System

Version/Model Number

SMNS0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180100

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

1f11f6ac-8776-473e-8807-58da9dd4c0b5

Public Version Date

November 14, 2019

Public Version Number

2

DI Record Publish Date

October 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-