Cleared Special

K151175 - ZONARE ZS3 Diagnostic Ultrasound System

K151175 is an FDA 510(k) clearance for ZONARE ZS3 Diagnostic Ultrasound System, manufactured by Zonare Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Special 510(k) pathway after a 14-day FDA review.

K151175 · Zonare Medical Systems, Inc. · Radiology device
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May 2015
Decision
14d
Days
Class 2
Risk

K151175 is an FDA 510(k) clearance for the ZONARE ZS3 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 Zonare Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 14 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 Zonare Medical Systems, Inc. devices

FDA 510(k) Submission Details - K151175

510(k) Number K151175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date May 15, 2015
Days to Decision 14 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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

All 923
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K151175.
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
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K150204 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2015
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