# K190042: Brainlab Elements Image Fusion Angio

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 25, 2019 after 106 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: 11 generations back to K913770 (1991). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170816: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM, Brainlab AG (2017) Summary page 4.

## Indications for use
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step. There are no demographic, regional or cultural limitations for patients. The system shall be used in a hospital office environment or rooms appropriate for surgical interventions.

Source page: https://510kreport.com/device/K190042
Methodology: https://510kreport.com/methodology