Who is the manufacturer of VBrain?

Vysioneer, Inc. filed the 510(k) submission for VBrain (K203235).

What is the FDA product code for VBrain?

QKB. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for VBrain?

510(k) clearance (submission type: Traditional).

Does VBrain use AI or machine learning?

Yes. VBrain (K203235) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for VBrain?

AccuContour™ (K191928); MIM - MRT Dosimetry (K182624).

Who can help prepare an FDA 510(k) submission like VBrain?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like VBrain get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

VBrain

K203235 · Vysioneer, Inc. · QKB · Mar 19, 2021 · Radiology

Device Facts

Record ID	K203235
Device Name	VBrain
Applicant	Vysioneer, Inc.
Product Code	QKB · Radiology
Decision Date	Mar 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

VBrain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor on MRI images for trained medical professionals' attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain is intended only for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas on axial T1 contrast-enhanced MRI images; It is not intended to be used with images of other brain tumors. The user must know the tumor type when they use VBrain. VBrain is intended to be used on adult patients only. Medical professionals must finalize (confirm or modify) the contours generated by VBrain, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system.

Device Story

VBrain is a software device for radiation therapy treatment planning. It takes axial T1 contrast-enhanced brain MRI images as input. Using deep learning neural networks, it automatically segments (contours) known brain metastases, meningiomas, and acoustic neuromas. The device operates on a PACS network; it receives patient scans and exports results as DICOM-RT objects (RTSTRUCT). It is used by trained medical professionals (e.g., radiation oncologists, dosimetrists) in clinical settings. The output is an initial contour set for professional review; clinicians must finalize, confirm, or modify these contours using external DICOM-RT compatible software (e.g., treatment planning systems). The device does not alter original images or perform diagnostic detection. By providing an automated starting point for contouring, it aims to assist clinical workflows, potentially improving efficiency in radiation therapy planning while maintaining the standard of care through mandatory human oversight.

Clinical Evidence

Retrospective, blinded, multicenter, multinational study (116 cases, 238 tumors from 4 institutions). Primary endpoints evaluated segmentation performance against ground truth (consensus of 3 board-certified radiation oncologists). Results: lesion-wise sensitivity 90.3% (95% CI: 86.1-93.7%); false-positive rate 0.681 tumors/case (95% CI: 0.500-0.879); lesion-wise Dice similarity coefficient 0.793 (95% CI: 0.775-0.811); average Hausdorff distance 5.0% (95% CI: 4.4-5.6%); centroid distance 5.6% (95% CI: 5.0-6.2%).

Technological Characteristics

Software-based radiological image processing device. Operates on Linux OS. Utilizes deep learning neural networks for automated segmentation. Inputs: axial T1 contrast-enhanced MRI. Outputs: DICOM-RT (RTSTRUCT). Configured for PACS network integration. Software classified as Major Level of Concern.

Indications for Use

Indicated for adult patients with known (diagnosed) brain metastases, meningiomas, or acoustic neuromas. Used by trained medical professionals (radiologists, oncologists, physicians, technologists, dosimetrists, physicists) to assist in radiation therapy treatment planning by providing initial GTV contours on axial T1 contrast-enhanced MRI images. Not for tumor detection/diagnosis. Not for use with other tumor types.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

AccuContour™ (K191928)
MIM - MRT Dosimetry (K182624)

Related Devices

K213628 — VBrain · Vysioneer, Inc. · Dec 16, 2021
K250427 — TAIMedImg DeepMets · Taiwan Medical Imaging Co., Ltd. · May 28, 2025
K252922 — Neosoma Brain Mets · Neosoma, Inc. · Dec 17, 2025
K212116 — VBrain-OAR · Vysioneer, Inc. · Oct 12, 2021
K173420 — Radiomics App v1.0 · Microsoft Corp. · Dec 27, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ March 19, 2021. Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION". Vysioneer Inc % Chiu S. Lin Consultant 33 Rogers Street, # 308 CAMBRIDGE MA 02142 Re: K203235 Trade/Device Name: VBrain Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QKB Dated: February 9, 2021 Received: February 10, 2021 Dear Chiu Lin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203235 Device Name V Brain ## Indications for Use (Describe) V Brain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors (i.e., region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. V Brain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor on MRI images for trained medical professionals' attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain is intended only for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas on axial T1 contrast-enhanced MRI images; It is not intended to be used with images of other brain tumors. The user must know the tumor type when they use VBrain. VBrain is intended to be used on adult patients only. Medical professionals must finalize (confirm or modify) the contours generated by VBrain, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image features the logo for Vysioneer, a company name displayed in a bold, sans-serif font. Above the name is a stylized 'V' shape, rendered in a shade of purple. Below the name is a horizontal purple line, and underneath that is the alphanumeric code 'K203235'. # Section 5 510(k) Summary #### 5.1 Submitter Vysioneer Inc. 33 Rogers St. #308, Cambridge, MA 02142 | Contact Person: | Jen-Tang Lu, PhD (Chief Executive Officer) | |------------------------|--------------------------------------------| | Phone: | 609-865-8659 | | Email: | jt@vysioneer.com | | Date Summary Prepared: | February 09, 2021 | #### 5.2 Device Name | Trade Name: | VBrain | |-----------------------------------|-----------------------------------------------------------------| | Common Name: | Radiological Image Processing Software for Radiation Therapy | | Regulation Number / Product Code: | 21 CFR 892.2050 / QKB | ### 5.3 PREDICATE DEVICE Primary Predicate #1: AccuContour™, K191928, Xiamen Manteia Technology LTD Primary Predicate #2: MIM - MRT Dosimetry, K182624, MIM Software Inc. #### Intended Use / Indications for Use 5.4 VBrain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Vysioneer. The logo consists of a stylized "V" shape in purple, with the company name "VYSIONEER" written in a sans-serif font below it, also in purple. The logo is simple and modern. VBrain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor on MRI images for trained medical professionals' attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain does not alter the original MRI image, nor does it intend to be used to detect turnors for diagnosis. VBrain is intended only for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas on axial T1 contrast-enhanced MRI images; It is not intended to be used with images of other brain tumors. The user must know the tumor type when they use VBrain is intended to be used on adult patients only. Medical professionals must finalize (confirm or modify) the contours generated by VBrain, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system. #### Device Description ર્ રંડ VBrain is a software device indicated for use in the analysis of brain MRI images. The device consists of image preprocessing, deep learning neural networks, and postprocessing components, and is intended to assist trained medical professionals, during clinical workflows of radiation therapy treatment planning, by highlighting and contouring known (diagnosed) brain tumors on the axial T1 contrast-enhanced MRI images. The software is configured to work on a PACS network. Upon user's request, it will patient scans or users can send corresponding MR images, and the device will utilize deep learning neural networks to generate contours for the detected/diagnosed brain tumors and export the results as DICOM-RT objects (using the RT Structure Set ROI Contour attribute, RTSTRUCT) back to the network. The medical professionals must finalize (confirm and modify) the contours produced by VBrain as necessary using an external platform that supports RT DICOM viewing/editing, such as a treatment planning system. #### Comparison with Predicate Devices 5.6 VBrain is substantially equivalent to a combination of the primary predicate devices AccuContour™ (K191928) and MIM - MRT Dosimetry (K182624). The proposed device, VBrain, and the primary predicates, AccuContour™ (K191928) and K182624 (MIM - MRT Dosimetry), are all software devices intended to be used in the workflow of radiation therapy by providing tools of segmenting (contouring) of tumors and/or organs on MRI and/or CT images. Both the proposed device and AccuContour™ (K191928) are AI-based (deep learning) software regulated under the Product Code QKB (Radiological Image Processing Software For Radiation Therapy). On the other hand, both the proposed device and K182624 (MIM - MRT Dosimetry) provide tools for tumor contouring. The only difference is that VBrain uses deep learning (neural networks) to automatically generate tumor contours as a starting point for user's review and edit, while K182624 (MIM - MRT Dosimetry) provides a semi-automatic {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Vysioneer. The logo consists of a stylized letter "V" formed by two diagonal lines in a purple color. Below the symbol, the word "VYSIONEER" is written in a sans-serif font, also in purple. A thin purple line is located below the word. tool (propagation tool) that requires user's input to start the image segmentation (contouring) process. Although the proposed new device. VBrain, uses a data-driven deep learning-based algorithm for contouring of known brain tumors, the primary predicate MIM - MRT Dosimetry (K182624) uses a semi-automatic algorithm that requires user's input to start the contouring process. The specific design of the proposed device does not raise different questions of safety and effectiveness, because the new device only provides initial object contours of known (diagnosed) brain tumors for the medical professionals' attention, which are meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. Medical professionals must use VBrain in conjunction with appropriate software to review and edit results generated automatically by VBrain. In addition, VBrain does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. The medical professionals must know the tumor type when they use VBrain. Consequently, the new device does not change any medical professionals' workflow planning procedure and therefore does not raise different questions of safety and effectiveness. Please see Table 5-1 comparing the intended use and key technological characteristics of the proposed device and the predicate devices. | Company | Vysioneer Inc. | Xiamen Manteia Technology LTD. (Primary) | MIM Software Inc. (Primary) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | VBrain | AccuContour™ | MIM - MRT Dosimetry | | 510k Number | Pending | K191928 | K182624 | | Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.2050 | | Classification | II | II | II | | Product Code | QKB | QKB | LLZ | | Intended Use/Indication for Use | VBrain is a software device intended to assist trained medical professionals, during their clinical workflows of radiation therapy treatment planning, by providing initial object contours of known (diagnosed) brain tumors (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. | It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. The product has two image process functions: (1) Deep learning contouring: it can automatically contour | MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported by ACR/NEMA DICOM 3.0. | | VBrain uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) brain tumor on MRI images for trained medical professionals' attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain is intended only for generating Gross Tumor Volume (GTV) contours of brain metastases, meningiomas, and acoustic neuromas on axial T1 contrast- enhanced MRI images; it is not intended to be used with images of other brain tumors. The user must know the tumor type when they use VBrain. VBrain is intended to be used on adult patients only. Medical professionals must finalize (confirm or modify) the contours generated by VBrain, as necessary, using an external platform available at the facility that supports DICOM- RT viewing/editing functions, such as image visualization software and treatment planning system | the organ-at-risk, including head and neck, thorax, abdomen and pelvis (for both male and female), (2) Automatic Registration, and (3) Manual Contour. It also has the following general functions: (1) Receive, add/edit/delete, transmit, input/export, medical images and DICOM data; (2) Patient management; (3) Review of processed images; (4) Open and Save of files. | MIM assists in the following indications: • Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects. • Create, display and print reports from medical images. • Registration, fusion display, and review of medical images for diagnosis, treatment evaluation, and treatment planning. • Evaluation of cardiac left ventricular end- diastolic volume, end-systolic volume, and ejection fraction. • Localization and definition of objects, such as tumors and normal tissues in medical images. • Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. • Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans | | | | | | • Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres). • Calculating absorbed radiation dose as a result of administering a radionuclide. | | | | | When using device clinically, the user should only use FDA approved radiopharmaceuticals. If using with unapproved ones, this device should only be used for research purposes. | | | | | Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using an FDA-approved printer for the diagnosis of digital mammography images. | | | | | Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images. The software is not to be used for mammography CAD. | | Segmentation (Contouring) Technology | Deep learning | Deep learning | Atlas-based algorithm and propagation tools (requiring user's input to | | | | | start the image segmentation process) | | Operating System | Linux operating system | Microsoft Windows | Microsoft Windows and Apple macOS operating systems…