Catalog Number

-

Brand Name

RayStation

Version/Model Number

11.0

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

K211867

Product Code

MUJ

Product Code Name

System, Planning, Radiation Therapy Treatment

Public Device Record Key

d7e72fd7-7ced-4ea0-a396-4dc313e5a73b

Public Version Date

September 23, 2021

Public Version Number

1

DI Record Publish Date

September 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-