Hisense LDC Monitor HMD2G21/HMD3G21/HMD5G21 - HMD3G21
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160347 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 Hisense LDC Monitor HMD2G21/HMD3G21/HMD5G21 is a diagnostic radiology display device designed for the visualisation of digital medical images. These monitors provide high-resolution imaging support for radiologists and medical practitioners to review and analyse radiographic studies, including X-rays, CT scans, and other diagnostic modalities.
These monitors are intended for use in clinical radiology settings and are supplied as reusable medical devices. They comply with FDA 510(k) clearance (K160347) and EU MDR regulations, with a classification under product code PGY. The devices are reviewed by the Radiology (RA) advisory committee and are intended for general diagnostic radiology applications, excluding digital mammography for the HMD2G21 model.
Frequently asked questions
Are these monitors intended for use with digital mammography imaging, and if not, which models are excluded from this application?
No, these Hisense LDC monitors are not intended for digital mammography. Specifically, the HMD2G21 model is explicitly excluded from use with digital mammography, while the HMD3G21 and HMD5G21 models are designed for general diagnostic radiology applications like X-rays and CT scans.
How are these monitors classified under regulatory frameworks, and which advisory committee oversees their review?
These monitors fall under FDA classification 2 and are reviewed by the Radiology (RA) advisory committee. They are also compliant with EU MDR regulations and carry the product code PGY, indicating their intended use in diagnostic radiology settings.
Are these monitors reusable or single-use, and what does that mean for maintenance and cleaning protocols?
These monitors are reusable medical devices, meaning they are designed for repeated use in clinical settings. Since they are not single-use, proper cleaning, disinfection, and maintenance protocols must be followed to ensure hygiene and longevity, as outlined in the manufacturer’s instructions.
What are the key differences between the HMD2G21, HMD3G21, and HMD5G21 models, and how might they impact clinical workflows?
The HMD2G21, HMD3G21, and HMD5G21 models are differentiated by their intended diagnostic applications and likely technical specifications (not explicitly listed here). The HMD2G21 is excluded from digital mammography, while the others are designed for broader radiology use. Clinicians should refer to the manufacturer’s documentation for model-specific features like resolution, connectivity, or ergonomic design to determine which best fits their workflow.
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: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21, Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 by QINGDAO HISENSE ..., Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160347 | Class II | Active |
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Manufacturer
- Manufacturer
- Qingdao Hisense Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K160347 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026