Duns Number:514775571
Device Description: The SafeCT is a software package of a PACS server, which is connected to the clinics' Loca The SafeCT is a software package of a PACS server, which is connected to the clinics' LocalArea Network (LAN), receives, processes and transfers CT images, using the DICOM protocol.The processing enhances image quality by reduction of the image noise.
Catalog Number
-
Brand Name
SafeCT
Version/Model Number
1.2
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
K100372
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
b0789ddc-854b-4c7a-b6bf-5a5920696e6d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2018
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. | 2 |