Cleared Special

K160182 - LOGIQ S7 Expert

K160182 is the FDA 510(k) clearance for LOGIQ S7 Expert by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 30-day FDA review.

K160182 · Ge Healthcare · Radiology device
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Feb 2016
Decision
30d
Days
Class 2
Risk

K160182 is an FDA 510(k) clearance for the LOGIQ S7 Expert. 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 Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on February 26, 2016 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare devices

Submission Details

510(k) Number K160182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date February 26, 2016
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K160182.
Acclarix LX8 Diagnostic Ultrasound System
K160790 · Edan Instruments, Inc. · Apr 2016
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
K160277 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 2016
TE7 Diagnostic Ultrasound System
K160381 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
Voluson S6, Voluson S8, Voluson S10
K160184 · Ge Healthcare · Feb 2016
WS80A Diagnostic Ultrasound System
K153529 · Samsung Medison Co., Ltd. · Feb 2016
HM70A Diagnostic Ultrasound System
K153408 · Samsung Medison Co., Ltd. · Dec 2015