# K070205: Ziostation

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: Mar 23, 2007 after 60 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: 1 generation back to K061326 (2006). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061326: Voxar 3D Enterprise with Cardiametrix, Barcoview Mis Edinburgh (2006) Summary page 1.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Indications for use
ZIOSTATION is an image processing workstation software package designed to run on standard PC hardware. The required hardware consists of standard 'off-the-shelf' computer components. It receives image data from standard modalities (medical image scanning devices) or from image archives. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It can be used as a just a workstation or as a client-server within a network. It is intended for use by trained medical imaging professionals to aid in their reading and review of such data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammograpic 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/K070205
Methodology: https://510kreport.com/methodology