Catalog Number

IRT100

Brand Name

InsightRT CDS

Version/Model Number

IRT100

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151560

Product Code

MUJ

Product Code Name

System,Planning,Radiation Therapy Treatment

Public Device Record Key

93df8ffa-7c8f-4e35-b6fb-fe4060107b9a

Public Version Date

January 18, 2021

Public Version Number

5

DI Record Publish Date

August 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-