# K253452: Accuro 3S

- Pathway: 510(k) (Traditional)
- Applicant: Rivanna Medical, Inc.
- Decided: Jul 24, 2026 after 291 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 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care. Accuro 3S supports B-mode imaging and a SpineNav-AI™ image processing software. Accuro 3S clinical applications include: musculoskeletal conventional and superficial, and guidance for needle placement. A typical examination using Accuro 3S is guidance of neuraxial anesthesia. SafeTrack™ is intended to provide healthcare professionals with visual tools for magnetic tracking of a needle with respect to ultrasound image data in musculoskeletal conventional and superficial applications.

Source page: https://510kreport.com/device/K253452
Methodology: https://510kreport.com/methodology