# K082135: Showcase

- Pathway: 510(k) (Traditional)
- Applicant: Trillium Technology, Inc.
- Decided: Oct 21, 2008 after 84 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: 8 generations back to K935595 (1995). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020995: Efilm Workstation with Modules, Efilm Medical, Inc. (2002) Summary page 1.
- K060992: Syngo US Workplace, Siemens Medical Solutions (2006) Summary page 2.
- K061215: Volcano S51 Family of Imaging Systems, Volcano Corporation (2006) Summary page 2.

## Indications for use
ShowCase is diagnostic quality radiological viewing software. ShowCase can be used to receive, store, display and manipulate medical images and associated clinical data. This device is not intended for diagnosis of lossy compressed images.

Source page: https://510kreport.com/device/K082135
Methodology: https://510kreport.com/methodology