Duns Number:048148197
Device Description: Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and Proton Systems Radiation Therapy Beam Shaping Range Compensator is custom manufactured and designed by the customer for intensity modulation of external beam proton radiation therapy. Each Compensator is patient specific and for single use
Catalog Number
-
Brand Name
Proton Systems, LLC
Version/Model Number
25cm Wax Range Compensator
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
Yes
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
K121657
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
926bc313-0f6b-44a7-be36-f841de5dd360
Public Version Date
March 01, 2021
Public Version Number
3
DI Record Publish Date
December 02, 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. | 6 |