Duns Number:314546664
Device Description: The iBEAM® evo Extension H&N is designed to support the patient’s head and neck region and The iBEAM® evo Extension H&N is designed to support the patient’s head and neck region and extends off the end of the iBEAM® evo Couchtop by 400 mm. The small profile (omega shape) optimizes the access to the treatment area, facilitating the use of complex and non coplanar beam angles.
Catalog Number
P10105-413
Brand Name
iBEAM
Version/Model Number
P10105-413
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
-
Product Code
IXQ
Product Code Name
Table, Radiographic, Stationary Top
Public Device Record Key
dc7c555b-f559-4330-b858-57f6a3fdc713
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 23, 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. | 175 |