Catalog Number

NA

Brand Name

I2C (IBA Image-Guided Therapy Console)

Version/Model Number

adaPTinsight

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

-

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Public Device Record Key

1137a405-151c-4a06-b12a-f0ba7c591e64

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-