# K132963: Fusionsync, Chimaera Fusionsync

- Pathway: 510(k) (Traditional)
- Applicant: Chimaera GmbH
- Decided: Dec 16, 2013 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The device FusionSync contains automatic registration algorithms that are intended for the spatial synchronization of different series. The automatic algorithm is not intended for the registration of series from modalities other than: CT conventional MRi, PET or SPECT. In addition, the product contains a manual mode (non-automatic) that allows the registration via user interaction such that for example automatic registration results can be refined. The intended clinical use is to display different 3D series from the same patient in spatial synchronization as for example, but not limited to, followtip examinations. The displayed series can be visualized as MPR views with arbitrary 3D orientation. It is possible to overlay a registered series onto an MPR view. The spatial synchronization and optional overlay, based on the registration result, is intended to help the clinician to obtain a better understanding of the joint information of two registered images. The clinician retains the responsibility for making the diagnosis based on their standard procedures where the separate unregistered images are compared visually. FusionSync complements these clinical standard procedures.

Source page: https://510kreport.com/device/K132963
Methodology: https://510kreport.com/methodology