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ClariPulmo

ClariPI Inc. · Model ClariPulmo Plus · UDI-DI 08800046800259

LLZ Prescription

510(k) clearances

19,647

Adverse events (41 deaths)

554

Recalls

633

Facilities

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.

Recalls

Date	Firm	Reason
2026-07-22	Merge Healthcare, Inc.	Software issue may cause measurements to be displayed inaccurately.
2026-07-22	FUJIFILM Healthcare Americas Corporation	Software issue may cause the ruler measurement to be inaccurate.
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-30	Merge Healthcare, Inc.	Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st
2026-06-19	Boston Scientific Corporation	Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu
2026-05-08	GE Medical Systems SCS	GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches
2026-03-19	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide re
2026-03-05	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w
2026-01-30	GE Medical Systems, LLC	There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.