# K051809: Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Insight A/S
- Decided: Aug 15, 2005 after 41 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: 4 generations back to K945188 (1995). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042292: Isite Pacs, Stentor, Inc. (2004) Summary page 2.
- K011142: Aquarius Workstation, Terarecon,Inc. (2001) Summary page 2.
- K012086: Aquariusnet Server, Terarecon,Inc. (2001) Summary page 2.

## Most influential descendants
- K063392: Imco-Stat (2006), 1 descendant of its own
- K112480: View 1 Imaging (2011), 0 descendants of its own

## Indications for use
The Medical Insight EasyVizTM PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnostic clinical review of digital radiology images. The product utilizes the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows XP, Linux). The product interfaces to existing imaging equipment using the DICOM PS 3.1-2000 (Digital Imaging And Communications In Medicine) standard communication protocol as described and developed by ACR. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 M-pixel resolution and meets other technical specifications reviewed and accepted by the US FDA. The system does not permanently store or produce original medical images.

Source page: https://510kreport.com/device/K051809
Methodology: https://510kreport.com/methodology