Cleared Traditional

EPIQ 5 Diagnostic Ultrasound System (K163120) - FDA 510(k) Clearance

Also marketed or referenced as:
EPIQ 7 Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System Affiniti 70 Diagnostic Ultrasound System

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163120 · Philips Ultrasound, Inc. · Radiology device
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Jan 2017
Decision
63d
Days
Class 2
Risk

K163120 is an FDA 510(k) clearance for the EPIQ 5 Diagnostic 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 Ultrasound, Inc. (Andover, US). The FDA issued a Cleared decision on January 10, 2017 after a review of 63 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 Ultrasound, Inc. devices

Submission Details

510(k) Number K163120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2016
Decision Date January 10, 2017
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 633
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K163120.
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
K170277 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2017
LOGIQ P9 and LOGIQ P7
K163596 · Ge Healthcare · Feb 2017
Acclarix LX8 Diagnostic Ultrasound System
K162055 · Edan Instruments, Inc. · Jan 2017
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
Voluson E6, Voluson E8, Voluson E10
K162269 · Ge Healthcare · Oct 2016