Cleared Traditional

K143452 - LOGIQ P9, LOGIQ P7

K143452 is an FDA 510(k) clearance for LOGIQ P9, manufactured by Ge Healthcare. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K143452 · Ge Healthcare · Radiology device
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Jan 2015
Decision
58d
Days
Class 2
Risk

K143452 is an FDA 510(k) clearance for the LOGIQ P9, LOGIQ P7. 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 29, 2015 after a review of 58 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

FDA 510(k) Submission Details - K143452

510(k) Number K143452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date January 29, 2015
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
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 1099
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