# K181892: Ziostation2

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: Oct 9, 2018 after 88 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: 14 generations back to K926514 (1993). 276 ancestors in all.
1 later device descends from it; 1 cites it directly.
10 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151212: Ziostation2, Qi Imaging, LLC (2015) Summary page 5.
- K130552: CT Pulmonary Analysis, Qi Imaging, LLC (2014) Summary page 5.
- K130542: Synapse 3D Lung and Abdomen Analysis, Fujifilm Medical System U.S.A., Inc. (2013) Summary page 5.
- K112051: Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software, Broncus Technologies, Inc. (2011) Summary page 5.
- K141745: Iqqa-Bodyimaging Software, Edda Technology (2014) Summary page 5.
- K082427: Syngo MR B17, Siemens Medical Solutions USA, Inc. (2008) Summary page 5.
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 5.
- K063559: Achieva, Intera and Panorama 1.0T, Release 2.5, Philips Medical Systems (2007) Summary page 5.

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

## Indications for use
•This application is 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 image data (CT, MRI, Ultrasound, Digital X-ray, X-ray Angiography, PET, SPECT, Nuclear Medicine, Secondary Capture, Mammography, X-ray Radiofluoroscopic image, and RT Image) from modalities 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 only 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 this application is being offered.

Source page: https://510kreport.com/device/K181892
Methodology: https://510kreport.com/methodology