Catalog Number

-

Brand Name

AlignRT Plus

Version/Model Number

GateCT

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

K123371

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

60e22fe2-62fd-4a3e-b437-9bf363cb5efd

Public Version Date

October 01, 2021

Public Version Number

1

DI Record Publish Date

September 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-