# K203681: RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 9, 2021 after 113 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 K920879 (1992). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 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
- K223279: RT Elements (4.0) (2023), 1 descendant of its own
- K250440: RT Elements  (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (2025), 0 descendants of its own

## 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 Multiple Brain Mets SRS application as one RT Element provides optimized planning and display for cranial multi-metastases radiation treatment planning. The Cranial SRS application as one RT Element provides optimized planning and display for cranial radiation treatment planning. The Spine SRS application as one RT Element provides optimized planning and display for single spine metastases. The Cranial SRS w/ Cones application as one RT Element provides planning and display for functional diseases (e.g. trigeminal neuralgia) or cranial lesion radiation treatment. The RT QA application as one RT Element contains features for patient specific quality assurance. Use RT QA to recalculate patient treatment plans on a phantom to verify that the patient treatment plan fulfills the planning requirements. The Dose Review application as one RT Element contains features for review of isodose lines, review of DVHs, dose comparison and dose summation.

Source page: https://510kreport.com/device/K203681
Methodology: https://510kreport.com/methodology