Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)

FDA 510(k) K152030 · Qingdao Hisense Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK152030

Submission

Device name
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
Applicant
Qingdao Hisense Medical Equipment Co., Ltd.
Qing Dao, CN
Received
July 22, 2015
Decision date
September 16, 2015
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.

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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
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More from Eizo Corporation

510(k)DeviceDecision
K233841HD80 Series Ultrasound Diagnostic SystemIYN · Traditional 05/16/2024SE
K233439HD60 Series Ultrasound Diagnostic SystemIYN · Traditional 02/21/2024SE
K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DPGY · Traditional 11/17/2022SE
K222132Hisense LCD monitor HMD2G21S, HMD3G21SPGY · Traditional 11/08/2022SE
K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)PGY · Traditional 07/26/2022SE
K213862HD60 Series Ultrasound Diagnostic SystemIYN · Traditional 06/08/2022SE
K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21PGY · Traditional 03/03/2016SE
K151709Hi-Light Diagnostic Ultrasound SystemsIYO · Traditional 07/17/2015SE

Questions and answers

When was Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) cleared by the FDA?

Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (K152030) received a 510(k) decision of Substantially Equivalent on September 16, 2015, 56 days after the submission was received.

What is the product code of K152030?

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