Catalog Number

M1887TB

Brand Name

NA

Version/Model Number

TORSO ARRAY 1.0T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911806

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

96187b0d-d20f-45d9-9ea5-1ee1b480f09e

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

October 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-