# K121916: Intuition

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Apr 2, 2013 after 274 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 52 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011142: Aquarius Workstation, Terarecon,Inc. (2001)
- K012086: Aquariusnet Server, Terarecon,Inc. (2001)
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 1.
- K122136: Vitreaview, Vital Images, Inc. (2012). Cleared while this submission was under review Summary page 1.
- K061696: Iqqa-Liver Software, Edda Technology, Inc. (2006) Summary page 1.

## Most influential descendants
- K191585: iNtuition-Structural Heart Module (2019), 2 descendants of its own
- K250337: AiORTA - Plan (2025), 1 descendant of its own
- K254207: AiORTA - Plan v2.0 (2026), 0 descendants of its own
- K200274: CariCloud (2020), 0 descendants of its own
- K161061: IMPAX Volume Viewing 4.0 (2016), 0 descendants of its own

## Recalls of this device
- Jan 21, 2015 · Class II · Z-1070-2015: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.

## Indications for use
To receive, store, transmit, post-process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images, DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EST, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology. Visualization in 2D, 3D and 4D are supported for single or multiple datasets, or combinations thereof. Tools are provided to define and edit paths through structures such as centerlines, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such a centerline. Segmentation of regions of interest and quantitative analysis tools are provided, for images of vasculature, pathology and morphology, including distance, angle, volume, histogram, ratios thereof, and tracking of quantities over time. A database is provided to track and compare results using published comparison techniques such as RECIST and WHO. Calcium scoring for quantification of atherosclerotic plaque is supported. Support is provided for digital image processing to derive metadata or new images from input image sets, for internal use or for forwarding to other devices using the DICOM protocol. Image processing tools are provided to extract metadata to derive parametric images from combinations of multiple input images, such as temporal phases, or images co-located in space but acquired with different imaging parameters, such as different MR pulse sequences, or different CT image parameters (e.g. dual energy). iNtuition is designed for use by healthcare professionals and is intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions. Interpretation of mammographic images or digitized film screen images is supported only when the software is used without compression and with an FDA-Approved monitor that offers at least SMpixel resolution and meets other technical specifications reviewed and accepted by the FDA. iNtuitionMOBlLE provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. Not intended for diagnostic use when used via a web browser or mobile device.

Source page: https://510kreport.com/device/K121916
Methodology: https://510kreport.com/methodology