510(k) · Cleared
ClearedRadOncAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Informai · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jun 18, 2026 as substantially equivalent to K222803 (Oncospace, Inc., 2023) after a 269-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jun 18, 2026
- Review
- 269 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 deviceK253050 RadOncAIInformai · 2026
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 deviceK253050 RadOncAIInformai · 2026
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) | K253050 | RadOncAI | Informai | 2026 | — |
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…Oncospace 510(k) Submitter / Holder Sigrid Schoepel Oncospace, Inc. 510(k) Number K222803 Classification Class II Regulation Number 21 CFR § 892.5050… | 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 34 years and passes through 4 companies; a new generation was cleared every 3.4 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. 2026, 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?
RadOncAI is indicated for use in a clinical setting by radiation oncologists, medical physicists, and dosimetrists to configure and review radiotherapy treatment plans for adult patients with malignant or benign head-and-neck disease. The software accepts: CT-simulation scan Clinician-defined planning target volumes; and Clinician-supplied data of organs-at-risk (OARs) Using these inputs, RadOncAI generates a patient-specific preliminary dose…
Read the full statement (170 words)
RadOncAI is indicated for use in a clinical setting by radiation oncologists, medical physicists, and dosimetrists to configure and review radiotherapy treatment plans for adult patients with malignant or benign head-and-neck disease.
The software accepts:
CT-simulation scan
Clinician-defined planning target volumes; and
Clinician-supplied data of organs-at-risk (OARs)
Using these inputs, RadOncAI generates a patient-specific preliminary dose distribution that includes:
Estimated achievable dose coverage to the planning target volume(s); and
Estimated achievable sparing of surrounding OARs.
The directive derived from the AI-generated plan must be reviewed, revised and approved by a qualified professional before clinical implementation. The AI-generated dose distribution generated by the software is intended to be transferred to a compatible radiotherapy TPS or reviewed using DICOM-RT compliant software prior to further use in clinical workflows. RadOncAI is not intended for primary diagnosis, autonomous clinical decision-making, delivery of radiation, or use in patient populations, anatomic sites, or treatment modalities outside the indications stated above. Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253050: RadOncAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253050
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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