Cleared Traditional

K232985 - 24HR513C

K232985 is the FDA 510(k) clearance for 24HR513C by Lg Electronics.Inc. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K232985 · Lg Electronics.Inc · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
80d
Days
Class 2
Risk

K232985 is an FDA 510(k) clearance for the 24HR513C. 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 December 11, 2023 after a review of 80 days - a notably fast clearance cycle.

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: 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 Lg Electronics.Inc devices

Submission Details

510(k) Number K232985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date December 11, 2023
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
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 82
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K232985.
Medical Monitor (21HQ613D)
K240130 · Lg Electronics.Inc · Feb 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
K233897 · Shenzhen Beacon Display Technology Co., Ltd. · Feb 2024
RadiForce MX317W
K233465 · Eizo Corporation · Dec 2023
Nio Color 8MP (MDNC-8132)
K233693 · Barco N.V. · Dec 2023
12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
K231026 · Shenzhen Beacon Display Technology Co., Ltd. · Aug 2023
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
K232127 · Lg Electronics.Inc · Aug 2023