Catalog Number

30000581513X

Brand Name

Philips Radiology Smart Assistant

Version/Model Number

1.0

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

K212186

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

30585b7b-bebd-498d-af92-afe79fd98ffc

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

January 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-