510(k) · Cleared
ClearedWorkflow Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirada Medical, Ltd. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Jul 10, 2018 as substantially equivalent to K130393 (Mirada Medical, Ltd., 2013) after a 26-day review. Its family tree reaches back 12 generations to 1991. 25 later devices descend from it.
- Decided
- Jul 10, 2018
- Review
- 26 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 112 ancestors in all, the oldest K871859 (1987). 25 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK181572 Workflow BoxMirada Medical, Ltd. · 2018
- Descendant · cites it directly · 7 of its ownK200323 AutoContourRadformation, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
- Descendant · cites it directly · 6 of its ownK193252 Contour ProtegeAIMim Software, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK230685 AutoContour Model RADAC V3Radformation, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK210632 Contour ProtegeAIMim Software, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 1 generation backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- This deviceK181572 Workflow BoxMirada Medical, Ltd. · 2018
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K200323AutoContourRadformation, Inc. · 2020 · cites it directly7descendants
- K220598AutoContour Model RADAC V2Radformation, Inc. · 2022 · 2 generations on6descendants
- K193252Contour ProtegeAIMim Software, Inc. · 2020 · cites it directly6descendants
- K230685AutoContour Model RADAC V3Radformation, Inc. · 2023 · 3 generations on5descendants
- K210632Contour ProtegeAIMim Software, Inc. · 2021 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −1 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| 0 (this device) | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| +1 | K200323 | AutoContour | Radformation, Inc. | 2020 | — |
| +2 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022 | — |
| +1 | K193252 | Contour ProtegeAI | Mim Software, Inc. | 2020 | — |
| +3 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023 | — |
| +2 | K210632 | Contour ProtegeAI | Mim Software, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QKB device
- #1 K191928 AccuContourscore 32.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130393 | Mirada RTXSummary page 5…stantially Equivalent to the following Legally Marketed device: Predicate Devices 510(k) Number Trade Name Manufacturer K130393 Mirada RTx Mirada Medical Ltd. Intended Use Workflow Box is a system designed to allow users to… | 2013 |
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 112 ancestors have a recall of any class.
- Of its descendants, K200323 (Radformation, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K130393.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181572: Workflow Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181572
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026