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

VBrain

Name: VBrain
Brand: VBrain

VBrain is software intended to assist trained medical professionals during radiation therapy treatment planning by providing initial contours on axial contrast-enhanced brain MRI images.…

Registry build 21.09.26

VBrain is software intended to assist trained medical professionals during radiation therapy treatment planning by providing initial contours on axial contrast-enhanced brain MRI images.

The specified contours cover known (diagnosed) brain tumors and organs at risk in adult patients.

What the Filing Describes

The filing describes VBrain as an application for contouring brain MRI images and registering images from multiple modalities. It says the software is intended to generate contours for trained professionals’ attention and is for informational purposes.

VBrain does not alter the original MRI image and is not intended to detect tumors for diagnosis. The filing says it is not intended to replace the current standard practice of manual contouring.

2manufacturers in China registered for this device type

1catalogue number

3510(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 VBrain
Listed by	Vysioneer, Inc., United States
FDA product code	QKB
Device type	Radiological Image Processing Software For Radiation Therapy
Device class	Class 2
Regulation	21 CFR 892.2050
510(k)	K213628
Record published	2023-08-08
Record revised	2023-12-04 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for VBrain
Catalogue number	Size	Status
2.1.2		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
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
K213628	2021-12-16
K212116	2021-10-12
K203235	2021-03-19

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.