Catalog Number

CLL001009000

Brand Name

Unique Single Energy Medical Charged Particle Radiation Therapy System

Version/Model Number

9.1

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

K132705

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

e7df05e2-dfbe-4ed3-971a-d8b678b3d6c0

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-