FDA-cleared K242467

IQ-UIP

Imbio, Inc.

Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not...

Modality
CT/CTA
Anatomy
Chest/lungs, specifically radiological usual interstitial pneumonia pattern
Decision
2024-12-19
FDA-cleared K241847

Imbio PHA (4.0.0)

Imbio, Inc

The Imbio PHA Software device is designed to measure the maximal diameters of the right and left ventricles of the heart, the main pulmonary artery, and the ascending aorta from a...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2024-08-30