Limbus Contour

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 20230307win2.7avxModel v1.7.1Ref v1.7.x

by Limbus AI Inc.

Identity

Trade Name: Limbus Contour EUDAMEDFDA 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 learning 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: v1.7.1 EUDAMED
20230307win2.7avx EUDAMED
v1.7.x EUDAMED
1.7.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 learning 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: 00628011382177 EUDAMEDFDA UDI
Basic UDI-DI: B-00628011382177 EUDAMED
6280113821608Q EUDAMED
FDA Product Code: LLZ FDA UDI
EMDN Code: Z11010282 INSTRUMENTS FOR RADIOTHERAPY SIMULATION - SOFTWARE ACCESSORIES EUDAMED
GMDN Term: Radiation therapy software FDA UDI

Classification

Device Class: Class I EUDAMED
Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 892.2050 FDA UDI
Special Device Type: -1192 EUDAMED
Software EUDAMED
Market of Registration: France EUDAMED
Italy 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Limbus Contour by Limbus Ai Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-00628011382177	Class I	Active
EUDAMED	European Union	CE/MDD	B-00628011382177	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

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

Sources (3)

EUDAMED 40b5f4c8-b853-4a37-be22-0fb9a38b0bfc 61 fields · synced Jul 21, 2026
EUDAMED ef233db3-96f8-424c-8382-aceeaab7963c 61 fields · synced May 18, 2026
FDA UDI 5b4d6192-e54f-4303-9586-dad5003bbcec 33 fields · synced May 30, 2026