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

Limbus Contour

Name: Limbus Contour
Brand: Limbus Contour

Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained…

Registry build 21.09.26

Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set.dcm files).

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Limbus Contour
Listed by	Limbus AI, Canada
FDA product code	QKB
Device type	Radiological Image Processing Software For Radiation Therapy
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Complaint-file establishment, Manufacturer
Record published	2025-02-19

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Limbus Contour
Catalogue number	Size	Status
1.8.X		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
AI-Rad Companion Organs RT	Siemens Healthcare Limited	6
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

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
K241837	2024-10-09

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.