# K071077: .Decimal Aperture

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, Inc.
- Decided: May 18, 2007 after 31 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: 3 generations back to K000137 (2000). 7 ancestors in all.
4 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)
- K040804: .Decimal Tissue Compensator/Intensity Modulator, Southeastern Radiation Products, Inc. (2004) Summary page 1.

## Most influential descendants
- K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator (2012), 2 descendants of its own
- K132236: .Decimal Proton Aperture (2013), 0 descendants of its own
- K131150: Cura Compensator (2013), 0 descendants of its own
- K123893: Cura Collimator (2013), 0 descendants of its own

## Indications for use
In proton therapy for cancer, a proton beam is aimed at the cancerous tissue using a large "snout". The "snout" is rotated around the patient using a large, three-story gantry. While the patient lies on a treatment table, the gantry rotates around and points the snout at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires two custom-made, beam modifying, patient specific devices: a range compensators and apertures. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. The aperture is a brass plate with a 2D pattern/hole cut out of it, which defines the area that is to be treated with the proton beam. Apertures are generated out of the treatment planning system and are unique to each patient and each gantry angle (most patients will have 2-3 different gantry angles.) The outer dimensions/specifications are vendor specific, based upon the manufacturer of the proton delivery machines.

Source page: https://510kreport.com/device/K071077
Methodology: https://510kreport.com/methodology