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ClariPulmo

FDA UDIEUDAMED

Class II (US FDA UDI)

by ClariPI Inc.

Identity

Trade Name
ClariPulmo FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
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. FDA UDI
Model / Reference
ClariPulmo Plus FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08800046800259 FDA UDI
510(k) Number
K203783 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

ClariPulmo by ClariPI Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Cleared under the same submission

K203783 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ClariPI Inc.

Sources (2)

  • FDA UDI 9ebc8625-d09e-43ed-aca1-e817d3ddf76a 34 fields · synced Jun 17, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026