# K071894: Xebra Dicom Image Browser

- Pathway: 510(k) (Traditional)
- Applicant: Hx Technologies, Inc.
- Decided: Aug 16, 2007 after 38 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: 5 generations back to K896095 (1990). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023476: Unipacs Workstation, Universal Pacs, Inc. (2003) Summary page 1.
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001)

## Most influential descendants
- K090481: Demasq Imaging Spftware Device (2009), 1 descendant of its own
- K092328: Med-Seg, Model BTMS 1000 (2010), 0 descendants of its own

## Indications for use
Xebra DICOM Image Browser TM is a software application that is used for viewing medical images. The Xebra Image Viewer receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disk of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. Inaddition, the Xebra Image Viewer can be integrated with an institution's existing HIS, RIS, EMR, or EHR for a fully integrated electronic patient record. Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K071894
Methodology: https://510kreport.com/methodology