# K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator

- Pathway: 510(k) (Traditional)
- Applicant: Proton Systems
- Decided: Oct 23, 2012 after 140 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000137 (2000). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071077: .Decimal Aperture, .Decimal, Inc. (2007) Summary page 2.
- K071078: .Decimal Range Compensator, .Decimal, Inc. (2007) Summary page 2.

## Most influential descendants
- K132236: .Decimal Proton Aperture (2013), 0 descendants of its own
- K131150: Cura Compensator (2013), 0 descendants of its own

## Indications for use
Proton Systems' proton radiation therapy beam-shaping aperture and range compensator manufacturing service manufactures the solid apertures and range compensators for intensity modulation of external beam proton radiation therapy. The apertures and range compensators are designed by the customer's treatment planning system to block radiation from hilling critical structures and healthy tissue while guiding the radiation to the targeted area.

Source page: https://510kreport.com/device/K121657
Methodology: https://510kreport.com/methodology