# K260576: MeVis AVM Contour

- Pathway: 510(k) (Traditional)
- Applicant: MeVis Medical Solutions AG
- Decided: Jun 30, 2026 after 130 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio, Brainlab AG (2021) Summary page 6.

## Indications for use
MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans. The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning procedures to target specific brain regions. The created contours are intended for further review, editing and approval by radiosurgery/-therapy planning specialists in third-party radiosurgery/-therapy treatment planning systems (not part of this submission). The semi-automatic registration is restricted to/requires: • X-ray, 2D DSA and 3D CT images of the brain • X-ray images must be acquired in both frontal and sagittal direction Intended Patient Population MeVis AVM Contour is used for patients diagnosed with Arteriovenous Malformations (AVM) requiring stereotactic radiosurgery (SRS). These patients are adults, 18 years and older. Intended User Profile The intended users are qualified medical professionals, working in the field of neurosurgery or radiotherapy planning (Neurosurgeons and Radiation Oncologists).

Source page: https://510kreport.com/device/K260576
Methodology: https://510kreport.com/methodology