# K182529: Xperius Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Oct 23, 2018 after 39 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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). 141 ancestors in all.
No later device cites it as a predicate yet.
6 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163020: Xperius Ultrasound System, Philips Health Care (2016) Summary page 4.

## Indications for use
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D), Color Doppler, M-Mode, and Color Power Angio (CPA) modes. It is indicated for diagnostic ultrasound imaging, and fluid flow analysis in the following applications: Abdominal Peripheral Vessel MSK Small Organ Pediatric The clinical environments where the Xperius Ultrasound system can be used for are: hospitals, surgery centers, clinics, and physician offices

Source page: https://510kreport.com/device/K182529
Methodology: https://510kreport.com/methodology