Duns Number:122240021
Device Description: The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical co The Halcyon Bracket is an accessory to the 3D SCANNER system and provides an electrical connection to the 3D SCANNER motors when the 3D SCANNER Water Tank is used with the Varian Halcyon delivery system.
Catalog Number
1231405Z
Brand Name
Halcyon Bracket
Version/Model Number
1231405Z
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
K101992
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
74845683-d3c2-4949-b32a-a6270df406ea
Public Version Date
May 29, 2019
Public Version Number
1
DI Record Publish Date
May 21, 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 | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |