Catalog Number

XMSGP030A08.00-0.00

Brand Name

GammaPod™ Imager Loader and Couch

Version/Model Number

Model B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K180571

Product Code

IWB

Product Code Name

System, Radiation Therapy, Radionuclide

Public Device Record Key

373dd31d-f262-4d84-bc27-6428e6ea6f93

Public Version Date

April 16, 2019

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-