Cleared Traditional

K143345 - SIGNA Pioneer

K143345 is the FDA 510(k) clearance for SIGNA Pioneer by Ge Healthcare Japan Corporation. It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K143345 · Ge Healthcare Japan Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2015
Decision
231d
Days
Class 2
Risk

K143345 is an FDA 510(k) clearance for the SIGNA Pioneer. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Healthcare Japan Corporation (Hino-Shi, JP). The FDA issued a Cleared decision on July 10, 2015 after a review of 231 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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 Japan Corporation devices

Submission Details

510(k) Number K143345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2014
Decision Date July 10, 2015
Days to Decision 231 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
124d slower than avg
Panel avg: 107d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 813
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