Duns Number:048148197
Device Description: Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to bloc Proton Systems Radiation Therapy Beam-Shaping Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is patient specific and for single use.
Catalog Number
-
Brand Name
Proton Systems, LLC
Version/Model Number
18cm Brass 360 Aperture
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
11adc493-96e1-4067-927f-958b2fdc867e
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 |