Catalog Number

-

Brand Name

eRAD PACS Evolution

Version/Model Number

8.0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120995

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

45d0ff41-a642-4182-b259-686655e0f37e

Public Version Date

May 23, 2019

Public Version Number

5

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-