Duns Number:380807099
Device Description: Gating Module for Siemens 4D-CT
Catalog Number
SDX0361V1.0
Brand Name
SDX System
Version/Model Number
1.0
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
K121845
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
5250271e-2dea-471d-807e-5b60eef4a5ea
Public Version Date
December 31, 2018
Public Version Number
5
DI Record Publish Date
May 02, 2017
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. | 16 |