510(k) clearance

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

FDA 510(k) source

510(k) number

K262548

Applicant

Philips Ultrasound, LLC

Decision date

Sep 25, 2026

Date received

Jul 23, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

IYN

Device type

System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class II

Regulation

21 CFR 892.1550

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Bothell, WA, US