# K131447: Intuition - Tda, Tva, Parametric Mapping

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Dec 24, 2013 after 218 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: 10 generations back to K971684 (1997). 78 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 81 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)
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 1.
- K042203: Leonardo Syngo Cardiology Workstation, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 1.
- K110366: Syngo.CT Cardiac Function, Siemens AG (2011) Summary page 1.
- K052839: CT Perfusion 4, GE Healthcare (2006) Summary page 1.
- K121459: Syngo.MR Neurology, Siemens Medical Solutions USA, Inc. (2012) Summary page 1.

## Most influential descendants
- K200750: Neuro.Al Algorithm (2020), 1 descendant of its own
- K220349: TeraRecon Neuro (2022), 0 descendants of its own

## Indications for use
iNtuition-TDA, TVA, and Parametric Mapping are software modules which supports assessment of time-dependent behavior of image intensity, density, dimensions or volume of regions of interest over time, for volumetric or planar dynamic image types such as CT or MR. Parametric mapping tools encode in color various parameters derived from the temporal or spatial characteristics of the planar or volumetric data. 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. iNtuition-TDA, TVA and Parametric Mapping are iNtution based software features with dedicated workflows and basic tools and thus support post-processing, displaying and manipulation of reports and medical images from acquisition devices and visualization in 2D, 3D and 4D for single or multiple datasets, or combinations thereof. iNtuition-TDA, TVA, Paramietric Mapping are designed for use by healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K131447
Methodology: https://510kreport.com/methodology