Catalog Number

RX370-ARBK

Brand Name

RadiForce®

Version/Model Number

RX370

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

K211491

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

5753bbca-0d44-4c30-b410-b22f1dce75fc

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-