Cleared Special

K260680 - EPIQ Series Diagnostic Ultrasound Systems

Also marketed or referenced as:
Affiniti Series Diagnostic Ultrasound Systems

K260680 is the FDA 510(k) clearance for EPIQ Series Diagnostic Ultrasound Systems by Philips Ultrasound, LLC. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 86-day FDA review.

K260680 · Philips Ultrasound, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
86d
Days
Class 2
Risk

K260680 is an FDA 510(k) clearance for the EPIQ Series Diagnostic Ultrasound Systems. 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 May 27, 2026 after a review of 86 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 K260680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date May 27, 2026
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
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 779
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