# K232331: InVision Precision LVEF (LVEF)

- Pathway: 510(k) (Traditional)
- Applicant: InVision Medical Technology Corporation
- Decided: Apr 25, 2024 after 265 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: 15 generations back to K935595 (1995). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210747: Caption Interpretation Automated Ejection Fraction Software, Caption Health (2022) Summary page 4.

## Indications for use
In Vision Precision LVEF is used to process previously acquired trans thoracic cardiac ultrasound images, store images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. In Vision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.

Source page: https://510kreport.com/device/K232331
Methodology: https://510kreport.com/methodology