# K151212: Ziostation2

- Pathway: 510(k) (Traditional)
- Applicant: Qi Imaging, LLC
- Decided: Nov 4, 2015 after 182 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: 11 generations back to K971684 (1997). 139 ancestors in all.
2 later devices descend from it; 1 cites it directly.
9 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070205: Ziostation, Ziosoft, Inc. (2007) Summary page 5.
- K083446: Cardiac Function Analysis, Calcium Scoring, Ziosoft, Inc. (2009) Summary page 5.
- K073138: Cardiq Express Version 2.0, GE Medical Systems (2008) Summary page 5.
- K111336: EBW NM 2.0, Philips Medical Systems (Cleveland), Inc. (2011) Summary page 5.
- K063324: Pet Vcar, GE Healthcare (2007) Summary page 5.
- K052839: CT Perfusion 4, GE Healthcare (2006) Summary page 5.
- K112531: Vitrea CT Myocardial Analysis, Vital Images, Inc. (2011) Summary page 5.
- K092013: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2009) Summary page 5.
- K110834: AW Volumeshare 5 with Angioviz Option, GE Healthcare (2011) Summary page 5.
- K110186: Synapse 3D Liver Analysis, Fujifilm Medical System U.S.A., Inc. (2011) Summary page 5.
- K121676: 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant, Ge Medical Systems, LLC (2012) Summary page 5.
- K110151: Achieva R4 1.5T and Achieva R4 3.0T, Philips Health Care (2011) Summary page 5.
- K130960: Suresubtraction Ortho, Toshibamedical Systems Corporation (2013) Summary page 5.
- K031261: Card EP, GE Medical Systems (2003) Summary page 5.
- K122578: Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) Planning, Vital Images, Inc. (2013) Summary page 5.

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

## Indications for use
Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources. This application software receives medical images from modalities (medical image scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication. printing, and management of medical images. This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered.

Source page: https://510kreport.com/device/K151212
Methodology: https://510kreport.com/methodology