# K200315: Ziostation2

- Pathway: 510(k) (Traditional)
- Applicant: Ziosoft, Inc.
- Decided: May 5, 2020 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: 15 generations back to K926514 (1993). 294 ancestors in all.
No later device cites it as a predicate yet.
10 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181892: Ziostation2, Ziosoft, Inc. (2018) Summary page 5.
- K150757: syngo.CT Dual Energy, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.
- K133589: Somatom Force, Siemens Medical Solutions USA, Inc. (2014) Summary page 5.
- K121072: Somatom Definition Flash, Siemens Medical Systems, Inc. (2012) Summary page 5.

## Indications for use
• This application software 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.

Source page: https://510kreport.com/device/K200315
Methodology: https://510kreport.com/methodology