# K213438: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Adaptiiv
- Decided: Jan 19, 2022 after 89 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: 6 generations back to K971367 (1997). 7 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K180289: 3D Bolus Software, 3D Bolus, Inc. (2018) Summary page 4.

## Most influential descendants
- 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 and 3D Brachy applications are indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy, and surface brachytherapy. Users may choose to send the Stereolithography (STL) files to Adaptiiv Medical Technologies Inc. to 3D print the external beam radiation therapy accessories to the specification of the prescribing radiation therapy professional or 3D print either external beam or surface brachytherapy accessories in-house. If 3D printing is performed by Adaptiiv Medical Technologies Inc., 3D printed accessories will be sent to the requesting care center for the final quality control and acceptance by the trained radiation therapy personnel. The use of 3D Bolus and 3D Brachy applications as well as the 3D printed radiation therapy accessories is by prescription only.

Source page: https://510kreport.com/device/K213438
Methodology: https://510kreport.com/methodology