# K103181: Zenis, Picture Archiving and Communications System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Aug 26, 2011 after 302 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 K842308 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042525: Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy Workstation, Ge Medical Systems Information Technologies (2004) Summary page 1.

## Indications for use
Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and. may be part of a larger PACS configuration.

Source page: https://510kreport.com/device/K103181
Methodology: https://510kreport.com/methodology