Catalog Number

-

Brand Name

IBA Proton Therapy System – Proteus 235

Version/Model Number

Proteus PLUS/Proteus ONE

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

K163500

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Public Device Record Key

5f7f7467-12f8-49fc-b6ed-2c16efcee981

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-