Radiation_oncology
RadOncAI
InformAI, Inc.
FDA
FDA-cleared AI medical device
Software for radiation oncologists, medical physicists and dosimetrists that takes a CT-simulation scan, clinician-defined planning target volumes and clinician-supplied organ-at-risk data for adult head-and-neck disease and generates a patient-specific preliminary dose distribution, which must be reviewed, revised and approved by a qualified professional and transferred to a compatible treatment-planning system before clinical use.
FDA Submission Metadata
- Submission number
- K253050
- Decision date
- June 2026
- FDA panel
- Radiology
- Product code
- MUJ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA