Flat Panel Display ME183L
510(k) K030272
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030272 | Date25 Apr 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The Flat Panel Display ME183L is a Flat Panel Display (FDA Product Code: LLZ) designed for medical imaging applications. It features an 18.1-inch monochrome TFT active matrix LCD with a display area of 359.0mm × 287.2mm and a pixel pitch of 0.2805mm × 0.2805mm. This device provides high-resolution visual output, supporting resolutions from 640 × 480 (VGA) to 1280 × 1024 (SXGA), and is optimized for radiology workflows. Its design ensures clear, stable imaging for diagnostic purposes.
The ME183L is supplied as a standalone medical-grade display, intended for integration with Picture Archiving and Communication Systems (PACS) or other radiology equipment. It is a reusable device, not sterile, and requires proper storage in a controlled environment to maintain performance. The display is FDA-cleared under 510(k) K030272 with a traditional review pathway, classified under the Radiology Advisory Committee. Accessories such as GA cable, S-Video, composite, and Y-Cb/Cr cables are available for signal input compatibility.
Other devices from Totoku Electric Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the ME183L Flat Panel Display designed for?
The ME183L is specifically engineered for medical imaging applications in radiology. Its 18.1-inch monochrome TFT active matrix LCD delivers high-resolution visual output, ensuring clear and stable imaging for diagnostic purposes. The display is optimized to integrate seamlessly with Picture Archiving and Communication Systems (PACS) or other radiology equipment, improving workflow efficiency and accuracy.
How is the ME183L Flat Panel Display supplied, and what are its key specifications?
The ME183L is supplied as a standalone medical-grade display, not sterile, and intended for reuse. It features an 18.1-inch monochrome LCD with a display area of 359.0mm × 287.2mm and a pixel pitch of 0.2805mm × 0.2805mm. The display supports resolutions ranging from 640 × 480 (VGA) to 1280 × 1024 (SXGA), making it versatile for various radiology imaging needs.
Is the ME183L Flat Panel Display sterile, and how should it be stored?
The ME183L is not a sterile device. Since it is reusable, proper storage in a controlled environment is essential to maintain its performance and longevity. Avoid exposure to extreme temperatures, humidity, or physical damage, as these factors can degrade the display quality over time.
What types of cables and accessories are available for the ME183L?
The ME183L is compatible with a range of signal input cables, including GA cable, S-Video, composite, and Y-Cb/Cr cables. These accessories ensure flexibility in connecting the display to various imaging devices, enhancing its adaptability within radiology settings.
What regulatory pathway was followed for the FDA clearance of the ME183L?
The ME183L Flat Panel Display received FDA clearance under the traditional review pathway through a 510(k) submission (K030272). It was classified under the Radiology Advisory Committee and determined to be substantially equivalent to a predicate device, ensuring compliance with medical imaging standards.