# K130393: Mirada RTX

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Medical, Ltd.
- Decided: Mar 20, 2013 after 33 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: 11 generations back to K913770 (1991). 111 ancestors in all.
36 later devices descend from it; 5 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102687: Mirada RT, Mirada Medical, Ltd. (2010) Summary page 1.
- K091373: Syngo Trued, Siemens Medical Solutions USA, Inc. (2009) Summary page 1.
- K093982: Xeleris 3 Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2010) Summary page 1.
- K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response, Velocity Medical Solutions, LLC (2008) Summary page 1.

## Most influential descendants
- K181572: Workflow Box (2018), 25 descendants of its own
- K132045: Advantagesim MD with CT Atlas-Based Contouring and RE-Planning Options (2013), 8 descendants of its own
- K200323: AutoContour (2020), 7 descendants of its own
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation (2014), 7 descendants of its own
- K220598: AutoContour Model RADAC V2 (2022), 6 descendants of its own

## Indications for use
RTx is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, radiation oncologists, dlosimetrists and physicists. RTx is a software application intended to display and visualize 20 & 3D multi-modal medical image data. The user may process, render, review, store, print and distribute DICOM 3.0 compliant datasets within the system and/or across computer networks. Supported modalities include static and gated CT, PET, MR, SPECT and planar NM. The user may also create, display, print, store and distribute reports resulting from interpretation of the dlatasets. RTx allows the user to register combinations of anatomical and functional images and display them with fused and non-fused displays to facilitate the comparison of image data by the user. The result of the registration operation can assist the user in assessing changes in image data, either within or between examinations and aims to help the user obtain a better understanding of the combined information that would otherwise have to be visually compared disjointedly. RTx provides a number of tools such as rulers and region of interests, which are intended to be used for the assessment of regions of an image to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of lesions, determination of treatment response and follow-up. RTx supports the loading and saving of DICOM RT objects and allows the user to define, import, display, transform, store and export such objects including regions of interest structures and dose volumes to radiation therapy planning systems. RTx allows the user to transform regions of interest associated with a particular imaging dlataset to another, supporting atlas-based contouring and rapid re-contouring of the same patient.

Source page: https://510kreport.com/device/K130393
Methodology: https://510kreport.com/methodology