Limbus Contour

GUDID 00628011382146

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).

Limbus Ai Inc.

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• Primary Device ID: 00628011382146
• NIH Device Record Key: bcab4976-03b6-408c-960e-06b8ae73b5c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Limbus Contour
• Version Model Number: 1.4.0
• Company DUNS: 204682821
• Company Name: Limbus Ai Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai
• Phone: 8336680077
• Email: support@limbus.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628011382146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201232

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-17
• Device Publish Date: 2021-06-09

On-Brand Devices [Limbus Contour]

• 00628011382146: Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform
• 00628011382153: Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform
• 00628011382160: Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform
• 00628011382177: Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform