Duns Number:314546664
Device Description: HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the I HexaPOD™ evo Module is a robotic couch top which fine adjusts the tumour position to the ISO center
Catalog Number
P10603-100
Brand Name
HexaPOD
Version/Model Number
P10603-100
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
K072898
Product Code
JAI
Product Code Name
Couch, Radiation Therapy, Powered
Public Device Record Key
b3ab27a9-f942-497d-8128-a8640f0a1be5
Public Version Date
October 12, 2021
Public Version Number
3
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 |