# K171594: Accuro

- Pathway: 510(k) (Traditional)
- Applicant: Rivanna Medical, LLC
- Decided: Oct 20, 2017 after 142 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K935595 (1995). 157 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132736: Accuro 3000 Ultrasound Scanner, Rivanna Medical, LLC (2014) Summary page 4.
- K161588: Vscan Extend, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 5.

## Most influential descendants
- K243937: Accuro 3S (2025), 2 descendants of its own
- K253452: Accuro 3S (2026), 0 descendants of its own
- K254021: Accuro XV (2026), 0 descendants of its own

## Indications for use
The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K171594
Methodology: https://510kreport.com/methodology