Cleared Traditional

K113613 - DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM

K113613 is an FDA 510(k) clearance for DIGITAL COLOR DOPPLER ULTRASOUND IMAGIN..., manufactured by Shantou Institute of Ultrasonic Instuments. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K113613 · Shantou Institute of Ultrasonic Instuments · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
192d
Days
Class 2
Risk

K113613 is an FDA 510(k) clearance for the DIGITAL COLOR DOPPLER ULTRASOUND IMAGING 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 Shantou Institute of Ultrasonic Instuments (Shantou, CN). The FDA issued a Cleared decision on June 15, 2012 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K113613

510(k) Number K113613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2011
Decision Date June 15, 2012
Days to Decision 192 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 107d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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K113613 · DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
Download PDF FDA Summary Shantou Institute of …