Duns Number:047138800
Device Description: ShowCase Image Center is an image management application that can automatically receive im ShowCase Image Center is an image management application that can automatically receive images from most DICOM capable imaging devices.
Catalog Number
IC020
Brand Name
SHOWCASE®
Version/Model Number
ShowCase Image Center
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)
Yes
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
-
Product Code
LMB
Product Code Name
Device, Digital Image Storage, Radiological
Public Device Record Key
c949e105-2237-439b-aa20-29bebd1fe1c0
Public Version Date
October 07, 2019
Public Version Number
2
DI Record Publish Date
April 26, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |