# K214093: VSP Bolus

- Pathway: 510(k) (Traditional)
- Applicant: 3D Systems
- Decided: Mar 30, 2022 after 92 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). 9 ancestors in all.
2 later devices descend 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)
- K091911: Bolus Compensator, .Decimal, Inc. (2009) Summary page 4.

## Most influential descendants
- K222639: VHA Radiotherapy Bolus (2022), 1 descendant of its own
- K253025: Ricoh 3D for Healthcare Bolus (2026), 0 descendants of its own

## Indications for use
The 3D Systems VSP 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. VSP Bolus is generated using input from radiation therapy professionals and medical imaging data to produce a bolus that is specific to the patient being treated. The VSP Bolus product is verified and approved by the radiation therapy professional prior to use on the patient, and is intended for patients of all ages receiving radiotherapy treatment. VSP Bolus was evaluated using 6 MV photons but has not been assessed for use with protons, electrons, or at orthovoltage X-rays.

Source page: https://510kreport.com/device/K214093
Methodology: https://510kreport.com/methodology