Cleared Traditional

EPIQ Series Diagnostic Ultrasound System (K243794) - FDA 510(k) Clearance

Also marketed or referenced as:
Affiniti Series Diagnostic Ultrasound System

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

K243794 · Philips Ultrasound, LLC · Radiology device
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Feb 2025
Decision
58d
Days
Class 2
Risk

K243794 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 February 6, 2025 after a review of 58 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, LLC devices

Submission Details

510(k) Number K243794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2024
Decision Date February 06, 2025
Days to Decision 58 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K243794.
V8 Diagnostic Ultrasound System
K243702 · Samsung Medison Co., Ltd. · Feb 2025
Vivid iq
K243620 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
Vivid T9/Vivid T8
K243628 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 2025
Digital Color Doppler Ultrasound System (P60 Series)
K241949 · Sonoscape Medical Corp. · Jan 2025
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
K243502 · Olympus Medical Systems Corporation · Jan 2025
Voluson Expert 18
K242168 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2024