# K163020: Xperius Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Nov 16, 2016 after 16 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K935595 (1995). 140 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 142 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162329: CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Philips Health Care (2016) Summary page 5.
- K153480: ClearVue850 Diagnostic Ultrasound System, Philips Health Care (2015) Summary page 6.

## Most influential descendants
- K182529: Xperius Ultrasound System (2018), 0 descendants of its own

## Recalls of this device
- May 28, 2025 · Class II · Z-2055-2025: Ultrasound transducer devices were refurbished beyond their useful life.

## Indications for use
Philips Xperius Ultrasound system is intended for diagnostic Ultrasound imaging in B (2D) and Color Doppler modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal Peripheral Vessel 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/K163020
Methodology: https://510kreport.com/methodology