PACSMATE MMD-5201M Monitor
510(k) K101796
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101796 | Date15 Jul 2010 | 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- Withdrawn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, 19 Sep 2026
The PACSMATE MMD-5201M Monitor is a 5-megapixel monochrome LCD display designed for medical imaging. It is classified as a diagnostic X-ray imaging system component, specifically a high-resolution monitor for digital radiography and mammography applications. The device supports the display of detailed medical images with a resolution of 2560 x 2048 pixels, enabling radiologists and diagnostic professionals to review and analyze high-fidelity visual data.
This monitor is intended for use in radiology departments and clinical imaging settings. It connects via a DVI interface to receive digital image data and features auto-detection technology to adjust display settings based on the connected graphics card. Supplied as a reusable device, it requires proper storage and handling to maintain image quality and functionality. The PACSMATE MMD-5201M Monitor holds FDA 510(k) clearance under K101796, issued in 2010, and is categorized under product code LLZ.
Other devices from Iei Technology Corp.
Questions
AI-generated answers, 19 Sep 2026
What types of medical imaging procedures is the PACSMATE MMD-5201M Monitor specifically designed to support in a clinical setting?
The PACSMATE MMD-5201M Monitor is designed for high-resolution display of digital images in radiology departments, particularly for digital radiography and mammography. Its 5-megapixel monochrome LCD and 2560 x 2048-pixel resolution ensure detailed visualization of medical images, making it ideal for reviewing and analyzing X-ray and mammographic studies.
How is the PACSMATE MMD-5201M Monitor connected to imaging systems, and does it require any special setup?
The monitor connects via a DVI interface to receive digital image data from imaging systems. It features auto-detection technology, which automatically adjusts display settings based on the connected graphics card, simplifying integration into existing workflows without manual configuration.
Is the PACSMATE MMD-5201M Monitor intended for single-use or reusable applications, and what storage considerations should be noted?
The PACSMATE MMD-5201M Monitor is not single-use; it is designed for reusable clinical applications. To maintain image quality and functionality, proper storage and handling are required, as the device’s performance depends on consistent operational conditions.
What regulatory pathway was followed for FDA clearance of the PACSMATE MMD-5201M Monitor, and when was it approved?
The PACSMATE MMD-5201M Monitor received FDA 510(k) clearance under the traditional review pathway, with a substantially equivalent (SESE) decision. The clearance was issued on July 15, 2010, under K-number K101796, and falls under product code LLZ for diagnostic X-ray imaging system components.