# K223396: Rapid RV/LV

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Feb 1, 2023 after 85 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.
1 later device descends from it; 1 cites it directly.
0 of 19 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.

## Most influential descendants
- K243378: Rapid MLS (2025), 0 descendants of its own

## Indications for use
The Rapid 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 for adults. Rapid RV/LV analyzes cases using machine learning algorithms to identify locations and measurements of the ventricles. The Rapid RV/LV device 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/K223396
Methodology: https://510kreport.com/methodology