# K180289: 3D Bolus Software

- Pathway: 510(k) (Traditional)
- Applicant: 3D Bolus, Inc.
- Decided: Jul 10, 2018 after 159 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K971367 (1997). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151369: .decimal p.d, .Decimal, LLC (2015) Summary page 4.

## Most influential descendants
- K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory (2022), 3 descendants of its own
- K243057: TrueFit Bolus; TrueFlex Bolus (2024), 1 descendant of its own
- K260308: TrueFit Bolus (2026), 0 descendants of its own
- K241318: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) (2024), 0 descendants of its own

## Indications for use
3D Bolus Software is indicated for, and intended for use as, an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.

Source page: https://510kreport.com/device/K180289
Methodology: https://510kreport.com/methodology