# K222639: VHA Radiotherapy Bolus

- Pathway: 510(k) (Traditional)
- Applicant: Vha Dean
- Decided: Nov 4, 2022 after 64 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: 6 generations back to K000137 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites 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)
- K214093: VSP Bolus, 3D Systems (2022) Summary page 5.

## Most influential descendants
- K253025: Ricoh 3D for Healthcare Bolus (2026), 0 descendants of its own

## Indications for use
The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses 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. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment. VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.

Source page: https://510kreport.com/device/K222639
Methodology: https://510kreport.com/methodology