# K230575: Limbus Contour

- Pathway: 510(k) (Special)
- Applicant: Limbus Ai, Inc.
- Decided: Apr 7, 2023 after 37 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954874 (1996). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201232: Limbus Contour, Limbus Ai, Inc. (2020) Summary page 4.

## Most influential descendants
- K241837: Limbus Contour (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K230575
Methodology: https://510kreport.com/methodology