# K180916: iNtuition-T1 Mapping and T2/T2* Mapping

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Sep 24, 2018 after 168 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 K940172 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140587: MR-CT Vva, Medis Medical Imaging Systems BV (2015) Summary page 4.

## Indications for use
iNtuition-T1 Mapping and T2/T2* Mapping are software modules that support the derivation and quantification of T1, T2 and T2* values from MR DICOM image pixel intensities and header information. The quantification of these parameters can be used to characterize tissues. Support is provided to overlay the T1, T2, and T2* values using colormaps on related MR images. Support is provided for using different colormaps to overlay different ranges of T1, T2 or T2* values and restrict the overlay to region of interest on the images. The MR images can be of simple planar scan like a single slice or volumetric or 4D scans of a body part. iNtuition-T1 Mapping and T2/T2* Mapping are iNtuition software features that can be used in multiple workflows or be used as basic tools for cardiac functionality. Additionally, the overlaid images can be captured and forwarded to other systems using standards such as DICOM or http protocol. Quantitative analysis is derived and available as text and graphical display. iNtuition- T1 Mapping and T2/T2* Mapping qualitative results and visualization can be used in a clinical setting on MR images of an individual patient and can be used to support the clinical decision making for the diagnosis of the patient. iNtuition- T1 Mapping and T2/T2* 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/K180916
Methodology: https://510kreport.com/methodology