Cleared Traditional

K262548 - EPIQ Inspira Series Diagnostic Ultrasound System

Also marketed or referenced as:
Affiniti Series Diagnostic Ultrasound System

K262548 is an FDA 510(k) clearance for EPIQ Inspira Series Diagnostic Ultrasou..., manufactured by Philips Ultrasound, LLC. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K262548 · Philips Ultrasound, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
64d
Days
Class 2
Risk

K262548 is an FDA 510(k) clearance for the EPIQ Inspira 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 September 25, 2026 after a review of 64 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

FDA 510(k) Submission Details - K262548

510(k) Number K262548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2026
Decision Date September 25, 2026
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

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

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