# K203256: Imbio RV/LV Software

- Pathway: 510(k) (Traditional)
- Applicant: Imbio, LLC
- Decided: Mar 9, 2021 after 125 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: 7 generations back to K945512 (1995). 16 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111373: CT42 Cardiac Computed Tomography (CT) Software, Circle Cardiovascular Imaging, Inc. (2011) Summary page 4.

## Most influential descendants
- K221100: Viz RV/LV (2022), 4 descendants of its own
- K230534: BriefCase-Quantification (2023), 3 descendants of its own
- K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (2022), 3 descendants of its own
- K220624: AI4CMR v1.0 (2022), 2 descendants of its own
- K240786: AutoChamber (2024), 1 descendant of its own

## Indications for use
The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The RV/LV software provides the user with annotated images showing ventricular 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/K203256
Methodology: https://510kreport.com/methodology