# K253025: Ricoh 3D for Healthcare Bolus

- Pathway: 510(k) (Traditional)
- Applicant: Ricoh 3D For Healthcare, LLC
- Decided: Apr 6, 2026 after 199 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: 7 generations back to K000137 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222639: VHA Radiotherapy Bolus, Vha Dean (2022) Summary page 5.

## Indications for use
The Ricoh 3D for Healthcare 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. Ricoh 3D for Healthcare 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 Ricoh 3D for Healthcare Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The Ricoh 3D for Healthcare Bolus is intended for patients of all ages receiving radiotherapy treatment. Ricoh 3D for Healthcare Bolus was evaluated using 6 MV photons, 6 MeV electrons, and 9 MeV electrons and has not been assessed for use with protons or orthovoltage X-rays.

Source page: https://510kreport.com/device/K253025
Methodology: https://510kreport.com/methodology