# K253050: RadOncAI

- Pathway: 510(k) (Traditional)
- Applicant: Informai
- Decided: Jun 18, 2026 after 269 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K920879 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222803: Oncospace, Oncospace, Inc. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253050
Methodology: https://510kreport.com/methodology