Medical Monitor (21HQ613D)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240130 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 Medical Monitor (21HQ613D) is a Display for Diagnostic Radiology, classified as a Class II medical device. It is designed to provide visual output for radiologic imaging systems, ensuring accurate and clear presentation of diagnostic images for radiologists and healthcare professionals during procedures.
This device is intended for use in radiology settings and is supplied as a reusable medical monitor. It adheres to regulatory standards, including FDA 510(k) clearance under Special Review and MDR compliance. The monitor is intended for integration with radiologic imaging equipment and does not require sterilization, as it is designed for repeated use in controlled environments.
Frequently asked questions
What is the primary purpose of the Medical Monitor (21HQ613D) in a clinical setting?
The Medical Monitor (21HQ613D) is designed specifically to provide clear and accurate visual output for radiologic imaging systems. It ensures radiologists and healthcare professionals can effectively review diagnostic images during procedures, improving diagnostic confidence and workflow efficiency in radiology departments.
Is this device intended for single-use or repeated use in controlled environments?
This device is intended for repeated use in controlled environments, such as radiology departments. It is classified as reusable and does not require sterilization, as it is designed for use in settings where contamination risks are minimized through proper maintenance protocols.
What regulatory pathways has this device undergone, and what does that mean for its use?
The Medical Monitor (21HQ613D) has obtained FDA 510(k) clearance under Special Review and complies with the EU Medical Device Regulation (MDR). This means it has been evaluated for safety and performance by regulatory authorities and is intended for integration with radiologic imaging equipment in approved clinical settings.
How is this monitor categorized in terms of medical device classification?
The Medical Monitor (21HQ613D) is classified as a Class II medical device under FDA regulations. This classification indicates it poses moderate risk and requires specific regulatory oversight to ensure its safety and effectiveness for diagnostic radiology applications.
What types of radiologic imaging systems is this monitor compatible with?
While the device is designed for integration with radiologic imaging systems, the exact compatibility depends on the specific imaging equipment. The provided OpenFDA registration numbers (e.g., 3009553444) indicate it is registered for use with various radiology-related systems, but final compatibility should be verified with the manufacturer or system documentation.
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 | K240130 | Class II | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- FDA Applicant
- Lg Electronics.Inc
Sources (2)
- FDA 510(k) K240130 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026