# K170750: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Aug 24, 2017 after 164 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010975 (2001). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170355: RayStation 6, RaySearch Laboratories AB (PUBL) (2017) Summary page 4.

## 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

## 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 "Multiple Brain Mets SRS" 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. 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. "RT QA" is an accessory to the RT Elements and 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.

Source page: https://510kreport.com/device/K170750
Methodology: https://510kreport.com/methodology