Catalog Number

781270

Brand Name

Ingenia

Version/Model Number

Smartpath to dStream for 3.0T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K162931,K173079,K183063

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

1d744488-05a7-4a85-97e7-b91afff13bba

Public Version Date

October 01, 2019

Public Version Number

1

DI Record Publish Date

September 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-