Cleared Traditional

K113663 - SONIXTABLET ULTRASOUND SCANNER

K113663 is an FDA 510(k) clearance for SONIXTABLET ULTRASOUND SCANNER, manufactured by Ultrasonix Medical Corporation. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K113663 · Ultrasonix Medical Corporation · Radiology device
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Jan 2012
Decision
43d
Days
Class 2
Risk

K113663 is an FDA 510(k) clearance for the SONIXTABLET ULTRASOUND SCANNER. 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 Ultrasonix Medical Corporation (Richmond, CA). The FDA issued a Cleared decision on January 25, 2012 after a review of 43 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 Ultrasonix Medical Corporation devices

FDA 510(k) Submission Details - K113663

510(k) Number K113663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2011
Decision Date January 25, 2012
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
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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