Duns Number:065626069
Device Description: Standalone software application
Catalog Number
-
Brand Name
eFilm Workstation
Version/Model Number
4.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K020995
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
e755a1a4-5a66-42b1-9bd3-1e25a5a76be9
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
December 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |