# K012086: Aquariusnet Server

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Sep 13, 2001 after 72 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: 3 generations back to K945188 (1995). 4 ancestors in all.
207 later devices descend from it; 7 cite it directly.
1 of 212 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972903: Imatron Ultra Access Workstation with Cardiac Software Extensions, Imatron, Inc. (1997) Summary page 1.
- K994329: Iivs Integrated Image Viewing Station, Terarecon,Inc. (2000) Summary page 1.

## Most influential descendants
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own
- K072205: Visage Pacs/CS, Release Version 5.0 (2007), 36 descendants of its own

## Indications for use
The AquariusNET Server acquires, stores, transmits, and enables compatible computers on a network to display medical images from medical scanning devices such as EBT, CT or MRI and patient reports of various types. Teleradiology, image acquisition, distribution, archiving, image manipulation, 3D and 4D visualization are supported. Calcium scoring from whole body computed tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

Source page: https://510kreport.com/device/K012086
Methodology: https://510kreport.com/methodology