# K203783: ClariPulmo

- Pathway: 510(k) (Traditional)
- Applicant: Claripi, Inc.
- Decided: Apr 6, 2022 after 464 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K954355 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103480: Thoracic Vcar, Ge Medical Systems, LLC (2011) Summary page 4.

## Indications for use
ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from the CT thoracic datasets. (The software is not intended for the diagnosis of pneumonia or COVID-19). The software provides 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 analysis results. ClariPulmo provides optional denoising and kernel normalization functions for improved quantification of lung CT images in cases when CT images were taken at low-dose conditions or with sharp reconstruction kernels.

Source page: https://510kreport.com/device/K203783
Methodology: https://510kreport.com/methodology