32HL512D, 31HN713D, 32HQ713D Diagnostic Radiology Display
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230845 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)
This device is a diagnostic radiology display, classified as a Class II medical device under FDA regulations. It is designed to present radiographic images for interpretation by healthcare professionals, ensuring accurate visualisation of diagnostic studies such as X-rays, CT scans, and MRIs in clinical settings.
The 32HL512D, 31HN713D, and 32HQ713D models are supplied as reusable diagnostic displays, intended for use in radiology departments. They comply with FDA 510(k) clearance and EU MDR authorisations, with specific FEI numbers listed for regulatory tracking. These displays are not single-use and require proper storage and maintenance to ensure image quality and device functionality.
Frequently asked questions
Are these displays intended for single-use or can they be reused in a clinical setting?
These displays (32HL512D, 31HN713D, and 32HQ713D) are explicitly designed as reusable diagnostic radiology displays for radiology departments. Since they are not classified as single-use, proper cleaning, maintenance, and storage protocols must be followed to preserve image quality and device functionality over repeated use.
What types of radiographic images can these displays accurately visualize, and how does that benefit radiology workflows?
These displays are engineered to present radiographic images—including X-rays, CT scans, and MRIs—for interpretation by healthcare professionals. Their high-quality visualization ensures accurate diagnostic assessment, reducing the risk of misinterpretation and streamlining workflows in radiology departments by providing clear, reliable imaging for clinical decision-making.
How do I verify the regulatory compliance of these devices when purchasing or implementing them?
These displays hold FDA 510(k) clearance (K230845) and comply with EU MDR authorizations, with multiple FEI numbers (e.g., 3009553444, 3000237660) for regulatory tracking. When purchasing, confirm the specific FEI number matches your region’s requirements, and check the product code (PGY) and registration numbers listed in the data to ensure alignment with your facility’s compliance needs.
What maintenance or storage considerations should be taken into account for these reusable diagnostic displays?
Since these displays are reusable, they require proper storage in a clean, controlled environment to prevent dust or damage and regular maintenance to sustain image quality and functionality. The manufacturer’s guidelines (not provided here) should outline specific cleaning procedures, but generally, avoiding exposure to moisture, extreme temperatures, or physical stress is critical to longevity and performance.
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 | K230845 | Class II | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- FDA Applicant
- Lg Electronics.Inc
Sources (2)
- FDA 510(k) K230845 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026