Cleared Special

EPIQ Series Diagnostic Ultrasound System (K251651) - FDA 510(k) Clearance

Also marketed or referenced as:
Affiniti Series Diagnostic Ultrasound System

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251651 · Philips Ultrasound, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
133d
Days
Class 2
Risk

K251651 is an FDA 510(k) clearance for the EPIQ Series 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, LLC (Bothell, US). The FDA issued a Cleared decision on October 9, 2025 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Philips Ultrasound, LLC devices

Submission Details

510(k) Number K251651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date October 09, 2025
Days to Decision 133 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K251651.
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K252074 · Canon Medical Systems Corporation · Oct 2025
LOGIQ E10s
K251963 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2025
LOGIQ E10
K251985 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2025
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
K250026 · Wuxi Hisky Medical Technologies Co., Ltd. · Oct 2025
FETOLY
K251368 · Diagnoly · Sep 2025
ViewMateTM Ultrasound System
K251820 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2025