# K254021: Accuro XV

- Pathway: 510(k) (Traditional)
- Applicant: Rivanna Medical, Inc.
- Decided: Apr 9, 2026 after 114 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: 19 generations back to K935595 (1995). 159 ancestors in all.
No later device cites it as a predicate yet.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243937: Accuro 3S, Rivanna Medical, Inc. (2025) Summary page 5.

## Indications for use
The Accuro XV is an ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro XV features a conformable three-dimensional medical ultrasound probe that automates large field-of-view image acquisitions after initial patient positioning. Accuro XV supports B-mode imaging for clinical applications that include: musculoskeletal conventional and superficial.

Source page: https://510kreport.com/device/K254021
Methodology: https://510kreport.com/methodology