FDA-cleared K203783

ClariPulmo

ClariPi Inc.

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...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-04-06
FDA-cleared K203785

ClariSIGMAM

ClariPi Inc.

Calculation of percent breast density and breast-density group information (BI-RADS A+B fatty versus C+D dense) as adjunctive information for interpreting physicians assessing...

Modality
Mammography/DBT
Anatomy
Breast tissue, including fibroglandular tissue and total breast area, assessed for each breast.
Decision
2021-09-10
FDA-cleared K212074

ClariCT.AI

ClariPi Inc.

ClariCT.AI receives, processes, and enhances supported CT DICOM images regardless of the labeled CT manufacturer or model for professional review within the cleared workflow.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2021-07-27
FDA-cleared K183460

ClariCT.AI

ClariPI Inc.

ClariCT.AI assists radiologists and specialists by denoising and enhancing DICOM CT images of the head, chest, heart, and abdomen, including low-dose filtered-back-projection and...

Modality
CT/CTA
Anatomy
Head, chest, heart, and abdomen
Decision
2019-06-13