510(k) · Cleared
ClearedMVision AI Segmentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MVision AI · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on May 3, 2022 as substantially equivalent to K181572 (Mirada Medical, Ltd., 2018) after a 232-day review. Its family tree reaches back 13 generations to 1991. 1 later device descends from it.
- Decided
- May 3, 2022
- Review
- 232 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 113 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 2 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 1 generation backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- This deviceK212915 MVision AI SegmentationMVision AI · 2022
- Descendant · cites it directly · 0 of its ownK241490 Contour+ (MVision AI Segmentation)Mvision AI OY · 2024
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 11 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 10 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 9 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 8 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 6 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 5 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 4 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 3 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 2 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 1 generation backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- This deviceK212915 MVision AI SegmentationMVision AI · 2022
Most influential descendants
Showing 1 of 1 · See all- K241490Contour+ (MVision AI Segmentation)Mvision AI OY · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −11 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −10 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −9 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −8 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −6 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −3 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −2 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −1 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| 0 (this device) | K212915 | MVision AI Segmentation | MVision AI | 2022 | — |
| +1 | K241490 | Contour+ (MVision AI Segmentation) | Mvision AI OY | 2024 | — |
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 |
|---|---|---|
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K181572 | Workflow BoxSummary page 4…QKB | 21 CFR §892.2050 | Class II Medical Device Predicate Device Predicate Device - Mirada Workflow Box, Software Medical Device (K181572) This predicate has not been subject to a design-related recall. Device Description MVision AI Segmentation is a software only m… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241490 | Contour+ (MVision AI Segmentation) | 2024 | 0 |
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 31 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 113 ancestors have a recall of any class.
- Of its descendants, K241490 (Mvision AI OY, 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K181572.
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. 2022, 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?
MVision AI Segmentation is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and…
Read the full statement (125 words)
MVision AI Segmentation is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows.
The system creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis in adult patients.
MVision AI Segmentation is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212915: MVision AI Segmentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212915
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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