Cleared Traditional

K082326 - ZONARE ULTRA ULTRASOUND SYSTEM

K082326 is an FDA 510(k) clearance for ZONARE ULTRA ULTRASOUND SYSTEM, manufactured by Zonare Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K082326 · Zonare Medical Systems, Inc. · Radiology device
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Oct 2008
Decision
55d
Days
Class 2
Risk

K082326 is an FDA 510(k) clearance for the ZONARE ULTRA 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 October 8, 2008 after a review of 55 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 Zonare Medical Systems, Inc. devices

FDA 510(k) Submission Details - K082326

510(k) Number K082326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date October 08, 2008
Days to Decision 55 days
Submission Type Traditional
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
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

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