Wide 2MP TFT LCD Monitor System IF 1902A
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032960 FDA 510(k)
- FDA Product Code
- LLZ 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 Wide 2MP TFT LCD Monitor System IF 1902A is a system for image processing in radiology. It features a 2MP TFT LCD display and is designed for use in medical imaging applications.
This device is manufactured by Wide Corporation and is supplied as a complete system. It has received FDA 510(k) clearance with K-number K032960, classified as a Class II device, and is intended for single use in radiology settings.
Frequently asked questions
What is the Wide 2MP TFT LCD Monitor System IF 1902A used for?
The Wide 2MP TFT LCD Monitor System IF 1902A is designed specifically for image processing in radiology applications, featuring a 2MP TFT LCD display to enhance medical imaging visualization.
How is the Wide 2MP TFT LCD Monitor System IF 1902A supplied?
The device is supplied as a complete system by Wide Corporation, ready for use in radiology settings without requiring additional components for basic operation.
Is the Wide 2MP TFT LCD Monitor System IF 1902A single-use or reusable?
The device is intended for single use in radiology settings, ensuring optimal performance and hygiene standards for medical imaging applications.
What regulatory status does the Wide 2MP TFT LCD Monitor System IF 1902A have?
The device has received FDA 510(k) clearance with K-number K032960, classified as a Class II device, and was determined to be substantially equivalent to predicate devices.
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: WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A - fda.innolitics.com, Wide 2MP TFT LCD Monitor If 1902A - allmed.wiki, Wide 2mp Tft Lcd Monitor System If 1902a - Beudamed, www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032960 | Class II | Active |
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Manufacturer
- Manufacturer
- Wide Corporation
Sources (1)
- FDA 510(k) K032960 24 fields · synced Oct 6, 2026