Cleared Traditional

K152195 - LOGIQ S8

K152195 is the FDA 510(k) clearance for LOGIQ S8 by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K152195 · Ge Healthcare · Radiology device
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Sep 2015
Decision
55d
Days
Class 2
Risk

K152195 is an FDA 510(k) clearance for the LOGIQ S8. 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 September 29, 2015 after a review of 55 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 Ge Healthcare devices

Submission Details

510(k) Number K152195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2015
Decision Date September 29, 2015
Days to Decision 55 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
52d faster than avg
Panel avg: 107d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K152195.
M9/M9CV/M9T Diagnostic Ultrasound System
K152543 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
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K152763 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
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K152545 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
LOGIQ E9, LOGIQ E9 XDClear 2.0
K152309 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2015
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K151451 · Toshibamedical Systems Corporation · Jul 2015