Catalog Number

-

Brand Name

RTx

Version/Model Number

1.8

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K130393

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

70778e9f-5bea-4e6d-ae05-7429a8d64f5e

Public Version Date

April 09, 2021

Public Version Number

3

DI Record Publish Date

March 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-