Cleared Traditional

K123249 - DIAGNOSTIC ULTRASOUND SYSTEM

K123249 is the FDA 510(k) clearance for DIAGNOSTIC ULTRASOUND SYSTEM by Edan Instruments, Inc.. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K123249 · Edan Instruments, Inc. · Radiology device
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Feb 2013
Decision
114d
Days
Class 2
Risk

K123249 is an FDA 510(k) clearance for the 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 Edan Instruments, Inc. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on February 8, 2013 after a review of 114 days - within the typical 510(k) review window.

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.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K123249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2012
Decision Date February 08, 2013
Days to Decision 114 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

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