510(k) K241837

Device

Limbus Contour

Applicant

Limbus Ai, Inc.

510(k) number

K241837

Product code

QKB

Decision

Substantially Equivalent (SESE)

Decision date

2024-10-09

Date received

2024-06-25

Regulation

892.2050

Classification name

Radiological Image Processing Software For Radiation Therapy

Medical specialty

Radiology

Review panel

Radiology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N

Source

FDA openFDA 510(k) dataset plus migrated FDA.report data