32HL512D

FDA 510(k) K192925 · Lg Electronics.Inc

Substantially Equivalent

510(k) numberK192925

Submission

Device name
32HL512D
Applicant
Lg Electronics.Inc
Pyeongtaek-Si, KR
Received
October 16, 2019
Decision date
March 13, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

Other 510(k)s with product code PGY

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K262783RadiForce MX247WPGY · Abbreviated Eizo Corporation09/01/2026SE
K261213Medical Monitor (40HT513D)PGY · Traditional Lg Electronics.Inc06/12/2026SE
K252780LCD Monitor (CL1902A, CL2103F)PGY · Traditional Shenzhen Beacon Display Technology Co., Ltd.12/19/2025SE
K253242LCD Monitor (C1216W, C822W, C821W)PGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/29/2025SE
K252030RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated Eizo Corporation08/28/2025SE
K243221RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated Eizo Corporation11/27/2024SE
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/25/2024SE
K242008Coronis OneLookPGY · Special Barco N.V.08/02/2024SE
K2411053MP Color LCD Monitor (CL-S301)PGY · Traditional Jvckenwood Corporation08/01/2024SE
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More from Eizo Corporation

510(k)DeviceDecision
K261614LED LCD Monitor (OEV-271H)GCJ · Traditional 07/17/2026SE
K261213Medical Monitor (40HT513D)PGY · Traditional 06/12/2026SE
K251209Medical Monitor (32HS710S)GCJ · Traditional 06/12/2025SE
K243439Medical Monitor (27HS714S)GCJ · Traditional 01/28/2025SE
K241402Medical Monitor (32HR734S)GCJ · Traditional 08/12/2024SE
K233599X-Clever (ASHK100G)LLZ · Traditional 03/18/2024SE
K240130Medical Monitor (21HQ613D)PGY · Special 02/15/2024SE
K23298524HR513CPGY · Traditional 12/11/2023SE
K23212721HQ513D, 32HL512D, 31HN713D, 32HQ713DPGY · Special 08/15/2023SE
K23084532HL512D, 31HN713D, 32HQ713DPGY · Special 04/27/2023SE

Questions and answers

When was 32HL512D cleared by the FDA?

32HL512D (K192925) received a 510(k) decision of Substantially Equivalent on March 13, 2020, 149 days after the submission was received.

What is the product code of K192925?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.