21HQ513D, 32HL512D, 31HN713D, 32HQ713D Diagnostic Display
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232127 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)
These devices are Diagnostic Displays designed for use in radiology imaging systems. They provide high-resolution visual output for interpreting radiographic images, including X-rays, CT scans, and other diagnostic modalities, ensuring accurate diagnostic assessment by radiologists and medical professionals.
The displays are intended for clinical use in radiology departments and are classified as Class II medical devices under FDA regulations. They are supplied as reusable equipment, with no indication of sterility requirements. Each model (21HQ513D, 32HL512D, 31HN713D, 32HQ713D) may vary in screen size or resolution, as specified in the manufacturer’s documentation. Authorized under FDA 510(k) clearance and MDR compliance, these devices adhere to regulatory standards for diagnostic imaging displays.
Frequently asked questions
What types of medical imaging are these diagnostic displays designed to support for accurate interpretation by radiologists?
These displays are specifically designed for interpreting radiographic images, including X-rays, CT scans, and other diagnostic imaging modalities commonly used in radiology. Their high-resolution output ensures that radiologists and medical professionals can assess images with precision, which is critical for accurate diagnosis and treatment planning.
Are these displays intended for single-use or reusable applications in a clinical setting?
These diagnostic displays are supplied as reusable equipment, meaning they are not designed for single-use. They are intended for long-term use in radiology departments, where they will be regularly utilized for interpreting various imaging studies.
How do I determine the specific screen size or resolution for each model (21HQ513D, 32HL512D, 31HN713D, 32HQ713D) before purchasing?
The exact screen size or resolution for each model is detailed in the manufacturer’s documentation provided by LG Electronics. Since specifications like these can vary between models, it’s best to consult the official product manual or contact LG Electronics directly for precise technical details tailored to your needs.
What regulatory pathways have these diagnostic displays undergone, and how does this affect their use in clinical settings?
These displays have undergone FDA 510(k) clearance and comply with the Medical Device Regulation (MDR). They are classified as Class II medical devices under FDA regulations, which means they have been evaluated for safety and effectiveness in radiology settings. Their compliance ensures they meet regulatory standards for diagnostic imaging displays, providing confidence in their reliability for clinical use.
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.
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 | K232127 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LG Electronics Inc.
- FDA Applicant
- Lg Electronics.Inc
Sources (2)
- FDA 510(k) K232127 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026