# K091911: Bolus Compensator

- Pathway: 510(k) (Special)
- Applicant: .Decimal, Inc.
- Decided: Jul 21, 2009 after 26 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: 4 generations back to K000137 (2000). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071078: .Decimal Range Compensator, .Decimal, Inc. (2007) Summary page 1.

## Most influential descendants
- K214093: VSP Bolus (2022), 2 descendants of its own
- K222639: VHA Radiotherapy Bolus (2022), 1 descendant of its own
- K211511: decimal Bolus (2021), 1 descendant of its own
- K252784: eXaSkin Plus (2026), 0 descendants of its own
- K253025: Ricoh 3D for Healthcare Bolus (2026), 0 descendants of its own

## Indications for use
Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.

Source page: https://510kreport.com/device/K091911
Methodology: https://510kreport.com/methodology