Catalog Number

-

Brand Name

iMRX System

Version/Model Number

Post Assy, 1.5T 16CH Cardiac Coil

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

Yes

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

K101813

Product Code

IZI

Product Code Name

System, X-Ray, Angiographic

Public Device Record Key

0dcb9e4e-ecaa-4e20-bf31-33375e90ef08

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-