510(k) · Cleared
ClearedOncoStudio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncosoft. Inc., · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Jul 2, 2026 as substantially equivalent to K242994 (Oncosoft. Co., Ltd., 2025) after a 135-day review. Its family tree reaches back 17 generations to 1991.
- Decided
- Jul 2, 2026
- Review
- 135 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K913770 (1991). 117 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 17 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations between
- 3 generations backK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
- 2 generations backK230685 AutoContour Model RADAC V3Radformation, Inc. · 2023
- 1 generation backK242994 OncoStudio (OS-01)Oncosoft. Co., Ltd. · 2025
- This deviceK260528 OncoStudioOncosoft. Inc., · 2026
Show all 17 generations
- Root · 17 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 16 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 15 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 14 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 13 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 12 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 11 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 10 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 9 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 8 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 7 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 6 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 5 generations backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- 4 generations backK200323 AutoContourRadformation, Inc. · 2020
- 3 generations backK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
- 2 generations backK230685 AutoContour Model RADAC V3Radformation, Inc. · 2023
- 1 generation backK242994 OncoStudio (OS-01)Oncosoft. Co., Ltd. · 2025
- This deviceK260528 OncoStudioOncosoft. Inc., · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −16 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −15 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −14 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −13 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −12 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −11 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −10 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −9 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −8 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −7 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −6 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −5 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| −4 | K200323 | AutoContour | Radformation, Inc. | 2020 | — |
| −3 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022 | — |
| −2 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023 | — |
| −1 | K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025 | — |
| 0 (this device) | K260528 | OncoStudio | Oncosoft. Inc., | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K242994 | OncoStudio (OS-01)Summary page 6…s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; Predicate Device 510(k) Number K242994 Trade/Device/Model Name OncoStudio Device Classification Name Medical Image Management and Pro… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 25 of the 117 ancestors have a recall of any class.
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. 2026, 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?
OncoStudio is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
It also supports the review, processing, and analysis of medical imaging and radiotherapy information within the radiation therapy planning workflow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260528: OncoStudio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260528
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026