510(k) · Cleared
ClearedDose+ (1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mvision AI OY · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 4, 2025 as substantially equivalent to K222803 (Oncospace, Inc., 2023) after a 237-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Sep 4, 2025
- Review
- 237 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K920879 (1992). 19 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 5 generations between
- 3 generations backK142108 RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery…Brainlab AG · 2014 · Recalled
- 2 generations backK202284 OncospaceOncospace, Inc. · 2021
- 1 generation backK222803 OncospaceOncospace, Inc. · 2023
- This deviceK250064 Dose+ (1.0)Mvision AI OY · 2025
Show all 9 generations
- Root · 9 generations backK920879 Brainscan Radiosurgery ModuleBrainlab · 1992 · Recalled
- 8 generations backK994413 BrainscanBrainlab AG · 2000 · Recalled
- 7 generations backK032511 Intuition ImageBrainlab AG · 2004
- 6 generations backK052220 Iplan RT FibertrackingBrainlab AG · 2005
- 5 generations backK080886 Iplan RT ImageBrainlab AG · 2008
- 4 generations backK103246 Iplan RTBrainlab AG · 2011 · Recalled
- 3 generations backK142108 RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery…Brainlab AG · 2014 · Recalled
- 2 generations backK202284 OncospaceOncospace, Inc. · 2021
- 1 generation backK222803 OncospaceOncospace, Inc. · 2023
- This deviceK250064 Dose+ (1.0)Mvision AI OY · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K920879 | Brainscan Radiosurgery Module | Brainlab | 1992 | 1 |
| −8 | K994413 | Brainscan | Brainlab AG | 2000 | 1 |
| −7 | K032511 | Intuition Image | Brainlab AG | 2004 | — |
| −6 | K052220 | Iplan RT Fibertracking | Brainlab AG | 2005 | — |
| −5 | K080886 | Iplan RT Image | Brainlab AG | 2008 | — |
| −4 | K103246 | Iplan RT | Brainlab AG | 2011 | 2 |
| −3 | K142108 | RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis | Brainlab AG | 2014 | 3 |
| −2 | K202284 | Oncospace | Oncospace, Inc. | 2021 | — |
| −1 | K222803 | Oncospace | Oncospace, Inc. | 2023 | — |
| 0 (this device) | K250064 | Dose+ (1.0) | Mvision AI OY | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K222803 | OncospaceSummary page 5…ew Panel Radiology Predicate Device Device Name Oncospace 510(k) Number K222803 Manufacturer Oncospace, Inc. This predicate has not been subject to a design-related recall.… | 2023 |
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 33 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 19 ancestors have a recall of any class.
- 2 other devices also cite its predicate K222803.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
Dose+ is a software-only medical device intended for use by qualified, trained radiation therapy professionals (including but not limited to medical physicists, radiation oncologists, and medical dosimetrists). The device is intended for male patients with localized prostate cancer or prostate cancer with pelvic lymph node involvement who are undergoing external beam radiation therapy treatment. The software uses machine learning-based algorithms to…
Read the full statement (143 words)
Dose+ is a software-only medical device intended for use by qualified, trained radiation therapy professionals (including but not limited to medical physicists, radiation oncologists, and medical dosimetrists). The device is intended for male patients with localized prostate cancer or prostate cancer with pelvic lymph node involvement who are undergoing external beam radiation therapy treatment. The software uses machine learning-based algorithms to automatically produce 3D dose distributions from patient-specific anatomical geometry and target dose prescription.
The predicted dose distribution output is required to be transferred to a radiotherapy treatment planning system (TPS) or reviewed by any DICOM-RT compliant software prior to further use in clinical workflows. Dose+ is intended to provide additional information during the treatment planning process facilitating the creation and review of a treatment plan.
Dose+ is not intended to be used for disease diagnosis and treatment decision purposes in clinical workflows
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250064: Dose+ (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250064
Report an extraction error
Are you the manufacturer?
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