# K170816: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Sep 26, 2017 after 190 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: 10 generations back to K913770 (1991). 121 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101228: Mirada XD, Mirada Medical, Ltd. (2010) Summary page 4.
- K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine), Brainlab AG (2012) Summary page 4.

## Most influential descendants
- K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (2021), 3 descendants of its own
- K223106: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion  (4.5);Fibertracking (2.0);BOLD MRI Mapping  (1.0);Image Fusion Angio  (1.0) (2023), 1 descendant of its own
- K260576: MeVis AVM Contour (2026), 0 descendants of its own
- K243633: Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) (2025), 0 descendants of its own
- K190042: Brainlab Elements Image Fusion Angio (2019), 0 descendants of its own

## Indications for use
The Image Fusion Element can be used in clinical workflows that benefit from the co-registration of image data. For example, this applies to navigation systems or medical data information terminals for image processing or image guided surgery in general as well as for treatment planning software for radiosurgery and radiotherapy. The device itself does not have specific clinical indications.

Source page: https://510kreport.com/device/K170816
Methodology: https://510kreport.com/methodology