510(k) · Cleared
ClearedOncoStudio (OS-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oncosoft. Co., Ltd. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Feb 24, 2025 as substantially equivalent to K230685 (Radformation, Inc., 2023) after a 151-day review. Its family tree reaches back 16 generations to 1991. 1 later device descends from it.
- Decided
- Feb 24, 2025
- Review
- 151 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K913770 (1991). 116 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations between
- 3 generations backK200323 AutoContourRadformation, Inc. · 2020
- 2 generations backK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
- 1 generation backK230685 AutoContour Model RADAC V3Radformation, Inc. · 2023
- This deviceK242994 OncoStudio (OS-01)Oncosoft. Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260528 OncoStudioOncosoft. Inc., · 2026
Show all 16 generations
- Root · 16 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 15 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 14 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 13 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 12 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 11 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 9 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 7 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 6 generations backK102687 Mirada RTMirada Medical, Ltd. · 2010
- 5 generations backK130393 Mirada RTXMirada Medical, Ltd. · 2013
- 4 generations backK181572 Workflow BoxMirada Medical, Ltd. · 2018
- 3 generations backK200323 AutoContourRadformation, Inc. · 2020
- 2 generations backK220598 AutoContour Model RADAC V2Radformation, Inc. · 2022
- 1 generation backK230685 AutoContour Model RADAC V3Radformation, Inc. · 2023
- This deviceK242994 OncoStudio (OS-01)Oncosoft. Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260528OncoStudioOncosoft. Inc., · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −15 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −14 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −13 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −12 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −11 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −9 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −7 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −6 | K102687 | Mirada RT | Mirada Medical, Ltd. | 2010 | — |
| −5 | K130393 | Mirada RTX | Mirada Medical, Ltd. | 2013 | — |
| −4 | K181572 | Workflow Box | Mirada Medical, Ltd. | 2018 | — |
| −3 | K200323 | AutoContour | Radformation, Inc. | 2020 | — |
| −2 | K220598 | AutoContour Model RADAC V2 | Radformation, Inc. | 2022 | — |
| −1 | K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | 2023 | — |
| 0 (this device) | K242994 | OncoStudio (OS-01) | Oncosoft. Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K230685 | AutoContour Model RADAC V3Summary page 6…vice(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; Predicate Device 510(k) Number K230685 Trade/Device/Model Name AutoContour Model RADAC V3 Device Classification Name Medical Image Manage… | 2023 |
| † | K232899 | AI-Rad Companion Organs RT | 2024 |
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 |
|---|---|---|---|
| K260528 | OncoStudio | 2026 | 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 34 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 25 of the 116 ancestors have a recall of any class.
- Of its descendants, K260528 (Oncosoft. Inc.,, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K230685.
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. 2025, 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 provides deep-learning-based automatic contouring to organs at risk in DICOM-RT
format from CT images. This software could be used as an initial contouring for the clinicians to be
confirmed by the radiation oncology department for treatment planning or other professions where a
segmented mask of organs is needed.
• Deep learning contouring from Head & Neck, Thorax, Abdomen, and Pelvis
• Generates DICOM-RT structure of contoured objects
• Manual Contouring
• Receive, transmit, store, retrieve, display, and process medical images and DICOM objects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242994: OncoStudio (OS-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242994
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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