Radiology · 510(k) · 2024
Limbus Contour
Limbus AI Inc.. Cleared by FDA on 9 October 2024 under submission K241837, product code QKB (radiological image processing software for radiation therapy). What FDA's record says, in FDA's words.
Device record · K241837
- Device. Limbus ContourDEVICE
- Company. Limbus AI Inc. (CA)COMPANY
- Decision. 9 October 2024, 510(k), substantially equivalent (traditional review); received 25 June 2024DECISION
- Panel. RadiologyPANEL
- Product code. QKB, Radiological Image Processing Software For Radiation TherapyCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (30 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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 T omography and Magnetic Resonance. The Limbus Contour Software assists in the following scenarios: • Operates in conjunction with radiation treatment planning 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. 510(k) Summary Page 1 K241837 LimbusAI LimbusContour510(k)Submission • Localizationanddefinitionof anatomical structures.LimbusContour isnot intendedfor usewithdigital mammography. VI.COMPARISONOFTECHNOLOGICALCHARACTERISTICSWITHTHEPREDICATEDEVICEThefollowingcharacteristicswerecomparedbetweenthesubject deviceandthepredicatedeviceinorder todemonstratesubstantial equivalence:• Indicationsfor Use–Thepredicateandsubject deviceareidentical withtheexceptionthat thepredicatehassupport for MacOSwhilethesubject devicedoesnot andthepredicatehaslessstructuresfor automaticcontouringavailable.• Materials–Thepredicateandsubject devicearesoftware-onlydevicesanddonotinherentlycontainmaterial.• Design–Thepredicateandsubject devicehaveequivalent designs.• […]
The product code's definition, from FDA's classification record. To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QKB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QKB, in Radiology, from Limbus AI Inc., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.