Radiology · 510(k) · 2021
RT-Mind-AI
MedMind Technology Co., Ltd.. Cleared by FDA on 15 December 2021 under submission K213155, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K213155
- Device. RT-Mind-AIDEVICE
- Company. MedMind Technology Co., Ltd. (CN)COMPANY
- Decision. 15 December 2021, 510(k), substantially equivalent (traditional review); received 28 September 2021DECISION
- Panel. RadiologyPANEL
- Product code. QKB, Radiological Image Processing Software For Radiation TherapyCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
It is used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation It is used by radiation oncology department to regi ster multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. Different Label/labeling Conform with 21CFR Part 801 Conform with 21CFR Part 801 Same Operation System Windows Windows Same Segmentation Features Algorithm Deep Learning Deep Learning Same Segmentation of Organ at Risk in the Anatomic Regions Head & Neck, Thorax, Abdomen &Pelvis Head & Neck, Thorax, Abdomen &Pelvis Same Compatible Modality Non-Contrast CT Non-Contrast CT Same Compatible Scanner Models No Limitation on scanner model, DICOM 3.0 compliance required No Limitation on scanner model, DICOM 3.0 compliance required Same Compatible Treatment Planning System No limitation on TPS mo del, DICOM 3.0 compliance required No limitation on TPS model, DICOM 3.0 compliance required Same Target Population Adults Only (greater than 21 years of age) Any patient type for whom Relevant multimodality images and segment (noncontrast) CT images are available. Different
The product code's definition, from FDA's classification record. 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 the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QKB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QKB, in Radiology, or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.