ClariPulmo

GUDID 08800046800020

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 physicianidentified 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.

ClariPI Inc.

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• Primary Device ID: 08800046800020
• NIH Device Record Key: dd79392a-e14b-43b3-888d-809b33a76b4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariPulmo
• Version Model Number: 2.0.1
• 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	08800046800020 [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: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by ClariPI Inc.

• 08800046800006 - ClariCT.AI: 2023-12-04
• 08800046800013 - ClariSIGMAM: 2023-09-08 ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calcu
• 08800046800020 - ClariPulmo: 2023-09-08ClariPulmo 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 physicianidentified 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.
• 08800046800020 - ClariPulmo: 2023-09-08 ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to aid the assessment of lung Abno
• 08800046800136 - ClariCT.AI: 2023-09-06 ClariCT.AI, is a software device intended for networking, communication, processing and enhancement of CT images in DICOM format