Cleared Traditional

K161224 - LOGIQ V5 Expert

K161224 is an FDA 510(k) clearance for LOGIQ V5 Expert, manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K161224 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology device
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Aug 2016
Decision
98d
Days
Class 2
Risk

K161224 is an FDA 510(k) clearance for the LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3. 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 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on August 5, 2016 after a review of 98 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 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC devices

FDA 510(k) Submission Details - K161224

510(k) Number K161224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date August 05, 2016
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
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

All 873
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K161224.
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