Cleared Traditional

K223423 - 32HQ713D (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223423 · Lg Electronics.Inc · Radiology device
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Mar 2023
Decision
107d
Days
Class 2
Risk

K223423 is an FDA 510(k) clearance for the 32HQ713D. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Lg Electronics.Inc (Gumi-Si, KR). The FDA issued a Cleared decision on March 1, 2023 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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 Lg Electronics.Inc devices

Submission Details

510(k) Number K223423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date March 01, 2023
Days to Decision 107 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
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 Consultant

Gms Consulting
JongHyun Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 133
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