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FDA-cleared K203783

ClariPulmo

ClariPi Inc.

Authorized purpose: Non-invasive CT image analysis that quantifies lung images and supports physician review of pulmonary tissue images and abnormalities.

Modality
CT/CTA
Anatomy
Chest/Lung; lungs/pulmonary tissue
Decision
2022-04-06
FDA-cleared K203785

ClariSIGMAM

ClariPi Inc.

Authorized purpose: 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 breast tissue composition; not a diagnostic aid.

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.

Authorized purpose: 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.

Authorized purpose: 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 iterative-reconstruction images, and transmitting processed images to a PACS workstation.

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