Limbus Contour v1.8.x

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref v1.8.x510(k) K230575

by Limbus AI Inc.

Identity

Trade Name: Limbus Contour FDA UDI
Generic Name: Radiation therapy software FDA UDI
Device Name: Limbus Contour EUDAMED
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). FDA UDI
Model / Reference: v1.8.x EUDAMED
1.8.X FDA UDI
Description: 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). FDA UDI

Identifiers

Primary DI / UDI-DI: 00628011382184 EUDAMEDFDA UDI
Basic UDI-DI: 6280113821608Q EUDAMED
FDA Product Code: QKB FDA UDI
EMDN Code: Z11010282 INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES EUDAMED
GMDN Term: Radiation therapy software FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Limbus Contour is an AI-powered automated contouring software classified under nomenclature code Z11010282, designed for radiation therapy planning. It employs deep learning algorithms to segment organs at risk (OARs) and clinical target volumes (CTVs) from imaging data, improving precision and efficiency in treatment planning.

This non-sterile, non-reusable software is supplied for use in radiation oncology settings and is not implantable or intended for reprocessing. It carries FDA 510(k) clearance under K230575 and is compliant with MDR regulations. The device is distributed by Limbus AI Inc. and Advena Limited, with a unique UDI (6280113821608Q) for traceability.

Frequently asked questions

What is the Limbus Contour used for in radiation therapy planning?

The Limbus Contour is an AI-powered software tool designed to automate the segmentation of organs at risk (OARs) and clinical target volumes (CTVs) from imaging data during radiation therapy planning. By leveraging deep learning algorithms, it enhances precision and efficiency in identifying these critical areas, helping clinicians optimize treatment plans.

Is the Limbus Contour software single-use or reusable, and how is it supplied?

The Limbus Contour is a non-reusable, non-sterile software solution supplied for use in radiation oncology settings. Since it is not a physical device requiring reprocessing, it is intended for repeated use within authorized systems, provided the software remains active and compliant with its specifications.

Who are the authorized distributors of the Limbus Contour, and how can I verify its authenticity?

The Limbus Contour is distributed by Limbus AI Inc. and Advena Limited. To verify authenticity, check the unique UDI (6280113821608Q) assigned to the device, ensuring traceability and compliance with regulatory requirements.

What regulatory pathways has the Limbus Contour followed, and which committees were involved?

The Limbus Contour received FDA 510(k) clearance under K230575, with a decision classified as *Substantially Equivalent* (SESE) by the Radiology (RA) advisory committee. It is also compliant with MDR regulations, ensuring adherence to both U.S. and European standards.

Does the Limbus Contour require any special handling or storage conditions?

As a non-sterile software solution, the Limbus Contour does not require specialized storage conditions like physical devices. However, it must be kept in an environment protected from unauthorized access or tampering to maintain data integrity and compliance with its intended use in radiation oncology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Limbus AI - Automatic Contouring for Radiation Therapy, Limbus Contour Review: Pricing, FDA Status & Alternatives | Physician ..., Limbus AI: Products, FDA Status & Funding | Physician AI Tools

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K230575	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K201232	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K241837	Class IIb	Active
EUDAMED	European Union	CE/MDR	6280113821608Q	Class IIb	Active

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Manufacturer

Manufacturer: Limbus AI Inc.
EUDAMED SRN: CA-MF-000025514
FDA Applicant: Limbus Ai, Inc.
Authorised Representative: Advena Limited MT-AR-000000234

Sources (3)

EUDAMED 77e1dd1f-1ba8-458b-be11-7460db749191 85 fields · synced Sep 18, 2026
FDA UDI 29fa5b30-392e-4191-965a-2f69ffbc8c09 33 fields · synced May 30, 2026
FDA 510(k) K230575 1 fields · synced May 18, 2026