Cleared Traditional

K223523 - Sonic DL

K223523 is the FDA 510(k) clearance for Sonic DL by Ge Medical Systems,Llc (Ge Healthcare). It is a Class 2 Radiology device (product code LNH) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K223523 · Ge Medical Systems,Llc (Ge Healthcare) · Radiology device
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May 2023
Decision
188d
Days
Class 2
Risk

K223523 is an FDA 510(k) clearance for the Sonic DL. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Medical Systems,Llc (Ge Healthcare) (Waukesha, US). The FDA issued a Cleared decision on May 30, 2023 after a review of 188 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 Medical Systems,Llc (Ge Healthcare) devices

Submission Details

510(k) Number K223523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2022
Decision Date May 30, 2023
Days to Decision 188 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
81d slower than avg
Panel avg: 107d · This submission: 188d
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.

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