# K220779: XD

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Medical, Ltd.
- Decided: Apr 15, 2022 after 29 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 K913770 (1991). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101228: Mirada XD, Mirada Medical, Ltd. (2010) Summary page 4.

## Indications for use
Mirada XD is intended to be used by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, and physicists. Mirada XD is a software application intended to display and visualize 2D & 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 CT, PET, MR, SPECT and planar NM. Supported image types include static, gated and dynamic. The user may also create, display, print, store and distribute reports resulting from interpretation of the datasets. Mirada XD 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. Mirada XD provides a number of tools such as rulers and region of interests 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. Mirada XD allows the user to define, import, transform, store and export regions of interest structures in DICOM RT format for use in radiation therapy planning systems.

Source page: https://510kreport.com/device/K220779
Methodology: https://510kreport.com/methodology