ClariPulmo

GUDID 08800046800259

ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abnormalities. The software is designed to support the physician in quantification of physician identified lung Abnormalities. The software will provide automated segmentation of the lungs and quantification of low-attenuation and high-attenuation areas within the segmented lungs by using predefined Hounsfield unit thresholds. The software displays by color the segmented lungs and identified Abnormality. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung Abnormalities in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.ClariPulmo also includes functionality for automated segmentation and quantification of organs included in the input CT images. Furthermore, it enables presentation of the quantified values in user-defined unit by using predefined HU thresholds and conversion table.

ClariPI Inc.

Radiology DICOM image processing application software

• Primary Device ID: 08800046800259
• NIH Device Record Key: 9ebc8625-d09e-43ed-aca1-e817d3ddf76a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariPulmo
• Version Model Number: ClariPulmo Plus
• Company DUNS: 693744312
• Company Name: ClariPI 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800046800259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203783

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: 2025-07-03
• Device Publish Date: 2025-06-25

On-Brand Devices [ClariPulmo]

• 08800046800020: ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to
• 08800046800259: ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to