# K254265: Helion Viewer Suite

- Pathway: 510(k) (Traditional)
- Applicant: Videomed Srl ( a Baxter Healthcare Corp company)
- Decided: May 27, 2026 after 148 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: 9 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191014: Elements Viewer, Brainlab AG (2020) Summary page 6.

## Indications for use
Helion Viewer Suite is a software device for displaying DICOM data and medical images. It includes functions for image review, image manipulation, annotations, and 3D visualization (Multiplanar reconstructions and 3D volume rendering). Helion Viewer Suite is not intended for primary image diagnosis or review of mammography images. Helion Viewer Suite is not intended as the primary source for identification of surgical structures. Helion Viewer Suite is not intended for performing any measurements for diagnostic, treatment, or therapy, but only for reference purposes

Source page: https://510kreport.com/device/K254265
Methodology: https://510kreport.com/methodology