Cleared Special

K190447 - 7400 Ultrasound Systems (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K190447 · Navigant Consulting - on Behalf of Esaote S.P.A. · Radiology device
Apr 2019
Decision
35d
Days
Class 2
Risk

K190447 is an FDA 510(k) clearance for the 7400 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 Navigant Consulting - on Behalf of Esaote S.P.A. (Indianapolis, US). The FDA issued a Cleared decision on April 1, 2019 after a review of 35 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.

Submission Details

510(k) Number K190447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2019
Decision Date April 01, 2019
Days to Decision 35 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 128d · This submission: 35d
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 168
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