# K153653: DICOM Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 13, 2016 after 114 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: 7 generations back to K896095 (1990). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093117: Digital Lightbox, Brainlab AG (2009) Summary page 4.
- K130624: CONI, Globalmed (2013) Summary page 4.

## Most influential descendants
- K191014: Elements Viewer (2020), 3 descendants of its own
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2024), 1 descendant of its own
- K254265: Helion Viewer Suite (2026), 0 descendants of its own
- K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2025), 0 descendants of its own

## Indications for use
DICOM Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.

Source page: https://510kreport.com/device/K153653
Methodology: https://510kreport.com/methodology