# K181572: Workflow Box

- Pathway: 510(k) (Traditional)
- Applicant: Mirada Medical, Ltd.
- Decided: Jul 10, 2018 after 26 days
- Product code: QKB (Radiological Image Processing Software For Radiation Therapy)
- 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: 12 generations back to K913770 (1991). 112 ancestors in all.
25 later devices descend from it; 6 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130393: Mirada RTX, Mirada Medical, Ltd. (2013) Summary page 5.

## Most influential descendants
- K200323: AutoContour (2020), 7 descendants of its own
- K220598: AutoContour Model RADAC V2 (2022), 6 descendants of its own
- K193252: Contour ProtegeAI (2020), 6 descendants of its own
- K230685: AutoContour Model RADAC V3 (2023), 5 descendants of its own
- K210632: Contour ProtegeAI (2021), 5 descendants of its own

## Indications for use
Workflow Box is a software system designed to allow users to route DICOM-compliant data to and from automated processing components. Supported modalities include CT, MR, RTSTRUCT Workflow Box includes processing components for automatically contouring imaging data using deformable image registration to support atlas based contouring, re-contouring of the same patient and machine learning based contouring. Workflow Box is a data routing and image processing tool which automatically applies contours to data which is sent to one or more of the included image processing workflows. Contours generated by Workflow Box may be used as an input to clinical workflows including, but not limited to, radiation therapy treatment planning. Workflow Box must be used in conjunction with appropriate software to review and edit results generated automatically by Workflow Box components, for example image visualization software must be used to facilitate the review and edit of contours generated by Workflow Box component applications. Workflow Box is intended to be used by trained medical professionals. Workflow Box is not intended to automatically detect lesions.

Source page: https://510kreport.com/device/K181572
Methodology: https://510kreport.com/methodology