Cleared Traditional

OncoStudio (OS-01)

K242994 · Oncosoft. Co., Ltd. · Radiology
Feb 2025
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K242994 is an FDA 510(k) clearance for the OncoStudio (OS-01), a Radiological Image Processing Software For Radiation Therapy (Class II — Special Controls, product code QKB), submitted by Oncosoft. Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on February 24, 2025, 151 days after receiving the submission on September 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K242994 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2024
Decision Date February 24, 2025
Days to Decision 151 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QKB — Radiological Image Processing Software For Radiation Therapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Semi-automatic Or Fully-automated Radiological Image Processing And Analysis Tools For Radiation Therapy. Software Implementing Artificial Intelligence (ai) Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Radiological Images. In These Devices, The Algorithm Training Images Typically Impact Device Performance. Ai Based Radiological Image Processing Software Is Intended To Be Used In The Workflow Of Radiation Therapy. Adaptive Ai Algorithms Are Not Within The Scope Of This Product Code. Primary Radiation Dose Calculation Or Plan Optimization For Treatment Planning Are Not Within Scope Of This Product Code.