Cleared Special

EPIQ Series Diagnostic Ultrasound System (K251455) - 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.

K251455 · Philips Ultrasound, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
73d
Days
Class 2
Risk

K251455 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 July 24, 2025 after a review of 73 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. 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. Low regulatory complexity profile. 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 K251455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2025
Decision Date July 24, 2025
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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 K251455.
Diagnostic Ultrasound System (MX7)
K251192 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · Siemens Medical Solutions USA, Inc. · Aug 2025
Venue
K251322 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2025
V8 Diagnostic Ultrasound System
K250999 · Samsung Medison Co., Ltd. · Jul 2025
Vivid Pioneer
K251169 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 2025
Sonosite LX Ultrasound System
K251830 · FUJIFILM Sonosite, Inc. · Jul 2025