# K061214: Aquariusaps Server

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: May 15, 2006 after 13 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: 6 generations back to K913770 (1991). 29 ancestors in all.
134 later devices descend from it; 8 cite it directly.
1 of 164 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012086: Aquariusnet Server, Terarecon,Inc. (2001)
- K041807: Lung Car 1.1, Medicsight (2004) Summary page 1.
- K042674: Colon Car 1.2, Medicsight (2004) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K011142: Aquarius Workstation, Terarecon,Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own
- K180336: syngo.MR Applications (2018), 21 descendants of its own

## Indications for use
The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K061214
Methodology: https://510kreport.com/methodology