Catalog Number

-

Brand Name

ProBeam® Rotating Gantry Proton Therapy System

Version/Model Number

3.5

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133191

Product Code

LHN

Product Code Name

System, radiation therapy, charged-particle, medical

Public Device Record Key

17a777cf-0d28-4142-b837-89a2c3aafee1

Public Version Date

October 04, 2019

Public Version Number

2

DI Record Publish Date

September 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-