What is FDA product code QKB?

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.

Radiology › Image Processing and StorageRadiological Image Processing Software For Radiation Therapy

AI-Rad Companion Organs RT

Name: AI-Rad Companion Organs RT
Brand: AI-Rad Companion Organs RT

AI-Rad Companion Organs RT is post-processing software that automatically contours organs at risk in CT images for radiotherapy planning. It creates radiotherapy structure-set objects from…

Registry build 21.09.26

AI-Rad Companion Organs RT is post-processing software that automatically contours organs at risk in CT images for radiotherapy planning. It creates radiotherapy structure-set objects from the image data for use in a treatment-planning workflow.

The generated contours can be reviewed and edited in an associated treatment-planning system before they are used in a plan.

Listed Item

Ai-Rad Companion Organs RT About Box

Image Transfer and Review

CT images reach the application through a PACS route or DICOM gateway. The teamplay infrastructure handles transfer of the image data and the resulting radiotherapy structures using the DICOM standard.

Structure sets are sent to a treatment-planning system or another configured DICOM node. Planning staff can preview the contours, reject unsuitable structures and review or edit the output in the treatment-planning system before incorporating it into a clinical plan.

2manufacturers in China registered for this device type

6catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Fujian (1), Beijing (1).

Chinese manufacturers registered for FDA product code QKB
Manufacturer	City	Province	Registered as	Device types
Manteia Technologies Co., Ltd.	Xiamen	Fujian	Manufacturer	3
Medmind Technology Co., Ltd.	Beijing	Beijing	Manufacturer	1

Record

Regulatory record for AI-Rad Companion Organs RT
Listed by	Siemens Healthcare Limited, Canada
FDA product code	QKB
Device type	Radiological Image Processing Software For Radiation Therapy
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Contract manufacturer, Manufacturer, Exporter
510(k)	K242745
Record published	2025-06-05
Record revised	2023-12-04 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2025-10-15

Catalogue Numbers

Catalogue numbers for AI-Rad Companion Organs RT
Catalogue number	Size	Status
11823875		In distribution
11545290		In distribution
11830482		In distribution
11665508		Withdrawn
11665278		Withdrawn
11294433		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
AccuContour	Manteia Technologies Co., Ltd.	4
ContourProtégéAI	MIM Software Inc.	3
ART-Plan	Therapanacea	3
AutoContour	Radformation, Inc.	2
DeepContour	Wisdom Medical Technologies	1
ContourProtégéAI – CT Abdomen	MIM Software Inc.	1
VBrain	Vysioneer, Inc.	1
ContourProtégéAI – MR Prostate	MIM Software Inc.	1
RT-Mind-AI	Medmind Technology Co., Ltd.	1
MRI Planner	Spectronic Medical AB	1
ContourProtégéAI – CT Prostate	MIM Software Inc.	1
Aview RT ACS	Coreline Soft Co., Ltd.	1

Showing 12 of 25. All products under Radiological Image Processing Software For Radiation Therapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K252548	2026-04-10
K242745	2025-03-27

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.