Cleared Traditional

K130659 - SPEQRT ULTRASOUND SYSTEM

K130659 is an FDA 510(k) clearance for SPEQRT ULTRASOUND SYSTEM, manufactured by Signostics Pty, Ltd.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K130659 · Signostics Pty, Ltd. · Radiology device
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Apr 2013
Decision
22d
Days
Class 2
Risk

K130659 is an FDA 510(k) clearance for the SPEQRT 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 Signostics Pty, Ltd. (Thebarton Sa, AU). The FDA issued a Cleared decision on April 3, 2013 after a review of 22 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 Signostics Pty, Ltd. devices

FDA 510(k) Submission Details - K130659

510(k) Number K130659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date April 03, 2013
Days to Decision 22 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
85d faster than avg
Panel avg: 107d · This submission: 22d
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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