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Lcd Monitor (HMD3C21S), Lcd Monitor (HMD5G21S)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221567

by Qingdao Hisense Medical Equipment Co., Ltd.

Identifiers

510(k) Number
K221567 FDA 510(k)
FDA Product Code
PGY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lcd Monitor (Hmd3c21s) and Lcd Monitor (Hmd5g21s) are display devices used in diagnostic radiology for displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. They are designed to accurately represent the subtle shading of medical images and guarantee consistent display over time in different terminals.

The devices are supplied as diagnostic monitors, with the Lcd Monitor (Hmd3c21s) being a Class 2 device with product code PGY. They have been cleared through the Traditional 510(k) pathway and have an FDA 510(k) clearance, indicated by the k number K221567. The devices are designed to be used in a medical setting, such as in radiology, and are intended for use by trained medical practitioners.

Frequently asked questions

What are the HMD3C21S and HMD5G21S LCD monitors used for?

They are used in diagnostic radiology for displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

What is the regulatory status of these devices?

They have been cleared through the Traditional 510(k) pathway and have an FDA 510(k) clearance, indicated by the k number K221567.

Are the HMD3C21S and HMD5G21S LCD monitors supplied sterile?

The description does not mention sterility, it only mentions that they are supplied as diagnostic monitors.

What product code do these devices have?

The Lcd Monitor (Hmd3c21s) is a Class 2 device with product code PGY.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (K221567) — FDA 510(k ..., HMD3C21S-Hisense Medical, K221567 FDA 510 (k) - LCD monitor (HMD3C21S), Diagnostic Monitor-Hisense Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Qingdao Hisense Medical Equipment Co., Ltd.

Sources (1)

  • FDA 510(k) K221567 24 fields · synced Oct 6, 2026