5MP Grayscale Flat Panel Display, Model, 6GF6201-5C$2# (Where $ = a-Z and # = 0-9)
by EIZO GmbH 510(k)
Active
510(k) K081357
Overview
The 5MP Grayscale Flat Panel Display, Model 6GF6201-5C$2#, is a diagnostic imaging display designed for viewing medical images. It features a 5-megapixel grayscale flat panel with a calibrated gamma response, supported by five internal lookup tables to ensure consistent image quality across various DVI graphic controller boards. This device is classified under product code LLZ and is intended for radiologic applications, providing clear and accurate visualisation of X-ray images.
This display is supplied as a reusable medical device and is intended for use in radiology settings. It requires no sterilisation but must be maintained according to manufacturer guidelines to ensure optimal performance. The device has received FDA 510(k) clearance under the Traditional pathway, with a decision date of September 5, 2008. No specific MRI safety classification is stated, and the device is available in a single model configuration as specified by the manufacturer.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081357 | Date5 Sep 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from EIZO GmbH
Questions
What is the primary use of the 5MP Grayscale Flat Panel Display, Model 6GF6201-5C$2#?
This device is specifically designed for diagnostic imaging in radiology settings. Its 5-megapixel grayscale flat panel provides clear and accurate visualization of X-ray images, ensuring reliable interpretation for clinical decision-making. The calibrated gamma response and internal lookup tables enhance consistency across different graphic controllers, making it ideal for radiologic applications.
How is the Eizo 6GF6201-5C$2# display supplied and maintained?
The display is supplied as a reusable medical device, meaning it is intended for repeated use within a radiology department. Unlike single-use devices, it does not require sterilization but must be maintained according to the manufacturer’s guidelines to preserve performance. Regular cleaning and adherence to operational protocols will extend its lifespan and ensure accurate image display.
Is this display available in multiple sizes or configurations?
The Eizo 6GF6201-5C$2# is offered in a single model configuration as specified by the manufacturer. While it features a 5-megapixel grayscale panel, no additional size or model variations are listed, ensuring a standardized solution for radiologic imaging needs.
What safety considerations should be noted when using this display?
The manufacturer does not specify an MRI safety classification for this device, meaning it should not be used in MRI environments unless explicitly confirmed safe by Eizo. Additionally, while it is reusable and not sterilized, proper maintenance—such as avoiding exposure to liquids or physical damage—is critical to prevent image artifacts or malfunctions. Always follow the manufacturer’s operational guidelines to ensure safe and effective use.
How does the calibrated gamma response and lookup tables benefit radiology workflows?
The calibrated gamma response ensures that image brightness and contrast remain consistent regardless of the graphic controller used, reducing variability in diagnostic interpretation. The five internal lookup tables further enhance this by standardizing color and grayscale reproduction, which is particularly important for detecting subtle differences in X-ray images. This consistency improves diagnostic accuracy and reduces the need for manual adjustments during workflows.