Catalog Number

-

Brand Name

ARIA Radiation Therapy Management Software

Version/Model Number

15.1

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

K173838

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

57a12e7d-fa6d-49f8-8d6f-f8ef5d5626d5

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-