# K252235: PVAD IQ Software

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasight, Ltd.
- Decided: Dec 18, 2025 after 154 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: 16 generations back to K935595 (1995). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210053: LVivo Software Application, Dia Imaging Analysis, Ltd. (2021) Summary page 5.

## Indications for use
The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures from cardiac ultrasound of patients 18 years old and above, with a Percutaneous Ventricular Assist Device (PVAD). Such use is typically utilized for clinical decision support by a qualified physician.

Source page: https://510kreport.com/device/K252235
Methodology: https://510kreport.com/methodology