# K142108: RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 16, 2014 after 134 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K920879 (1992). 16 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103246: Iplan RT, Brainlab AG (2011) Summary page 4.

## Most influential descendants
- K202284: Oncospace (2021), 4 descendants of its own
- K222803: Oncospace (2023), 3 descendants of its own
- K253050: RadOncAI (2026), 0 descendants of its own
- K250064: Dose+ (1.0) (2025), 0 descendants of its own
- K242748: Oncospace (2025), 0 descendants of its own

## Recalls of this device
- Mar 11, 2019 · Class II · Z-1205-2019: There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GP
- Nov 5, 2015 · Class II · Z-0647-2016: Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
- Nov 5, 2015 · Class II · Z-0648-2016: Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

## Indications for use
The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The “Dose Review” application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation. The “Brain Metastases” application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning. The “Adaptive Hybrid Surgery Analysis” application as one RT Element simulates an automated template-based radiation treatment plan. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms.

Source page: https://510kreport.com/device/K142108
Methodology: https://510kreport.com/methodology