RadOncAI— 510(k) K253050
Substantially EquivalentInformai
FDA 510(k) clearance K253050 for RadOncAI, Substantially Equivalent on 2026-06-18. Applicant: Informai. Device class: 2.
Summary
RadOncAI from Informai is filed under MUJ, radiation therapy treatment planning systems. The record doesn't describe the product beyond its name and the code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Informai filed from Houston, Texas. Review took 269 calendar days (September 22, 2025 to June 18, 2026).
Clearance details
- Applicant
- Informai
- Product code
- Product code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code MUJ
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