Cleared Traditional

K212116 - VBrain-OAR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212116 · Vysioneer, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
97d
Days
Class 2
Risk

K212116 is an FDA 510(k) clearance for the VBrain-OAR. Classified as Radiological Image Processing Software For Radiation Therapy (product code QKB), Class II - Special Controls.

Submitted by Vysioneer, Inc. (Cambridge, US). The FDA issued a Cleared decision on October 12, 2021 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vysioneer, Inc. devices

Submission Details

510(k) Number K212116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2021
Decision Date October 12, 2021
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 107d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKB Radiological Image Processing Software For Radiation Therapy
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QKB Radiological Image Processing Software For Radiation Therapy

All 45
Devices cleared under the same product code (QKB) and FDA review panel - the closest regulatory comparables to K212116.
DeepBT Detector-Plus
K252190 · Aitewan Biomedical Technology, Inc. · Apr 2026
AI-Rad Companion Organs RT
K252548 · Siemens Healthcare GmbH · Apr 2026
Contour ProtégéAI+
K253270 · Mim Software, Inc. · Mar 2026
AutoContour (RADAC V5)
K260509 · Radformation, Inc. · Mar 2026
Seg Pro V3 (RT-300)
K251306 · Ever Fortune.Ai, Co., Ltd. · Jan 2026
AccuContour 4.0
K251351 · Manteia Technologies Co., Ltd. · Jan 2026