OncoStudio (OS-01)— 510(k) K242994

Substantially Equivalent

Oncosoft. Co., Ltd.

FDA 510(k) clearance K242994 for OncoStudio (OS-01), Substantially Equivalent on 2025-02-24. Applicant: Oncosoft. Co., Ltd.. Device class: 2.

Clearance details

Applicant: Oncosoft. Co., Ltd.
Product code: Product code QKB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-09-26
Decision date: 2025-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QKB

K262452 — AutoContour (RADAC V6)2026-08-14
K261306 — AI Contouring (VA10A)2026-07-10
K260528 — OncoStudio2026-07-02
K252190 — DeepBT Detector-Plus2026-04-10
K252548 — AI-Rad Companion Organs RT2026-04-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.