Limbus Contour

Primary DI

00628011382177

Basic UDI-DI Code

B-00628011382177

Reference

20230307win2.7avx

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

No Longer On The Market

Manufacturer

Limbus AI Inc.

Limbus Contour is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal contours for input to radiation treatment planning. Supported image modalities are Computed Tomography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: ● Operates in conjunction with radiation treatment planning systems or DICOM viewing systems to load, save, and display medical images and contours for treatment evaluation and treatment planning. ● Creation, transformation, and modification of contours for applications including, but not limited to: transferring contours to radiotherapy treatment planning systems, aiding adaptive therapy and archiving contours for patient follow-up. ● Localization and definition of healthy anatomical structures. Limbus Contour is not intended for use with digital mammography. *** [2023-09-25] Limbus Contour has underwent a nonsignificant label change approved in accordance with the transitional provisions of Regulation (EU) 2017/745 Article 120, including amending Regulation (EU) 2023/607. As a result, LOT (i.e. software version/device model) and Reference/Catalogue number (i.e. build ID) updated to “v1.7.1” and “20230922win2.7avx”, respectively. There is no impact on existing indication of use, no changes to the design, no impacts on performance or established safety / hazards of the product. No changes were made to significantly affect the safety and effectiveness of the device. No new risks or modifications to existing risks were found with this change request.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).