Cleared Traditional

K163020 - Xperius Ultrasound System

K163020 is the FDA 510(k) clearance for Xperius Ultrasound System by Philips Health Care. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K163020 · Philips Health Care · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
16d
Days
Class 2
Risk

K163020 is an FDA 510(k) clearance for the Xperius Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Philips Health Care (Bothell, US). The FDA issued a Cleared decision on November 16, 2016 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Philips Health Care devices

Submission Details

510(k) Number K163020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date November 16, 2016
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 780
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K163020.
ACUSON P500 Ultrasound System
K163396 · Siemens Medical Solutions USA, Inc. · Jan 2017
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K162845 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2016
LOGIQ E9, LOGIQ E9 XDClear 2.0
K163077 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 2016
Xario 200 Diagnostic Ultrasound System V5.0
K162155 · Toshibamedical Systems Corporation · Nov 2016
MyLabSix CrystaLine
K162290 · Esaote, S.P.A. · Oct 2016
RS80A Diagnostic Ultrasound System
K153539 · Samsung Medison Co., Ltd. · Oct 2016