Cleared Traditional

K191864 - 21HK512D

K191864 is the FDA 510(k) clearance for 21HK512D by Lg Electronics.Inc. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K191864 · Lg Electronics.Inc · Radiology device
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Dec 2019
Decision
146d
Days
Class 2
Risk

K191864 is an FDA 510(k) clearance for the 21HK512D. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Lg Electronics.Inc (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on December 5, 2019 after a review of 146 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 K191864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2019
Decision Date December 05, 2019
Days to Decision 146 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
39d slower than avg
Panel avg: 107d · This submission: 146d
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 Peers - PGY Display, Diagnostic Radiology

All 82
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K191864.
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K191845 · Barco N.V. · Sep 2019
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K191137 · Jvckenwood Corporation · Jul 2019
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