RadOncAI— 510(k) K253050

Substantially Equivalent

Informai

FDA 510(k) clearance K253050 for RadOncAI, Substantially Equivalent on 2026-06-18. Applicant: Informai. Device class: 2.

Clearance details

Applicant
Informai
Product code
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
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