Catalog Number

ISS100S

Brand Name

InsightRT Software Suite Server

Version/Model Number

ISS100S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2018

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

f5163df1-0124-4dd6-a7ec-789be6afaabb

Public Version Date

August 02, 2018

Public Version Number

4

DI Record Publish Date

August 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-