# K241847: Imbio PHA (4.0.0)

- Pathway: 510(k) (Special)
- Applicant: Imbio, Inc.
- Decided: Aug 30, 2024 after 65 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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 K945512 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203256: Imbio RV/LV Software, Imbio, LLC (2021) Summary page 4.

## Indications for use
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 volumetric CTPA acquisition and report the RV/LV and Pa/Ao ratios. PHA analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the anatomy. The PHA software provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.

Source page: https://510kreport.com/device/K241847
Methodology: https://510kreport.com/methodology