Catalog Number

45980163082X

Brand Name

Pinnacle Radiation Therapy Planning System

Version/Model Number

16.4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 09, 2030

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

K170086

Product Code

MUJ

Product Code Name

System, planning, radiation therapy treatment

Public Device Record Key

8b217f94-a3cb-4b49-915a-a86eb8dec310

Public Version Date

August 06, 2021

Public Version Number

2

DI Record Publish Date

November 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-