Cleared Traditional

K213155 - RT-Mind-AI (FDA 510(k) Clearance)

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

K213155 · Medmind Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
78d
Days
Class 2
Risk

K213155 is an FDA 510(k) clearance for the RT-Mind-AI. Classified as Radiological Image Processing Software For Radiation Therapy (product code QKB), Class II - Special Controls.

Submitted by Medmind Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 15, 2021 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medmind Technology Co., Ltd. devices

Submission Details

510(k) Number K213155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date December 15, 2021
Days to Decision 78 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
29d faster than avg
Panel avg: 107d · This submission: 78d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K213155.
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