Cleared Traditional

K133034 - LOGIQ F SERIES

K133034 is the FDA 510(k) clearance for LOGIQ F SERIES by Ge Healthcare. It is a Class 2 Radiology device (product code IYN) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K133034 · Ge Healthcare · Radiology device
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Jan 2014
Decision
127d
Days
Class 2
Risk

K133034 is an FDA 510(k) clearance for the LOGIQ F SERIES. 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 January 31, 2014 after a review of 127 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 Healthcare devices

Submission Details

510(k) Number K133034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date January 31, 2014
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
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 K133034.
6200 / 6250 ULTRASOUND SYSTEM
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DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2014
LOGIQ E
K133533 · Ge Healthcare · Feb 2014
XARIO 100
K133277 · Toshibamedical Systems Corporation · Jan 2014
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
K133833 · Philips Ultrasound, Inc. · Jan 2014
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K133505 · Samsung Medison Co., Ltd. · Dec 2013