# K132236: .Decimal Proton Aperture

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, Inc.
- Decided: Oct 16, 2013 after 90 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000137 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator, Proton Systems (2012) Summary page 2.

## Indications for use
.decimal's Aperture manufacturing service manufactures the ring and solid care apertures for intensity modulation of external beam proton radiation therapy. The apertures are designed by the customers 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/K132236
Methodology: https://510kreport.com/methodology