15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K071794 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• 21.3 Inch (54cm) Monochrome LCD Monitor MDL2122A

  Class II

  FDA 510(k) K070370 Active Cleared 9 Mar 2007

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  Class II

  FDA 510(k) K081055 Active Cleared 4 Jun 2008

• Flat Panel Displays, Cdl Series

  Class II

  FDA 510(k) K030276 Active Cleared 25 Apr 2003

• 19-INCH (48CM) Color LCD Monitor CDL1904A

  Class II

  FDA 510(k) K051403 Active Cleared 14 Jul 2005

• 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)

  Class II

  FDA 510(k) K041737 Active Cleared 13 Jul 2004

• 21, 3-Inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A)

  Class II

  FDA 510(k) K040695 Active Cleared 7 Jun 2004

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• What is the primary purpose of the 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) in a clinical setting?

  This monitor is specifically designed for digital mammography systems, including Picture Archiving and Communication Systems (PACS) and full-field digital mammography (FFDM). Its high-resolution, grayscale display ensures radiologists and medical practitioners can visualize breast tissue with precision, aiding in accurate diagnostic evaluations.

• Is the 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) intended for single-use or reusable applications?

  The device is supplied as a reusable, non-sterile monitor. It is not intended for single-use, meaning it can be used repeatedly in clinical settings after proper cleaning and maintenance, as long as it remains functional and adheres to manufacturer guidelines.

• What size display does the 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) feature, and how does it enhance image quality?

  The monitor features a 21.3-inch (53 cm) display with advanced sub-pixel driving techniques. These features work together to improve image clarity and resolution, ensuring sharper and more detailed visualization of mammographic images for diagnostic purposes.

• How was the FDA authorization for the 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) determined, and what does this mean for its use?

  The device received FDA authorization through a 510(k) clearance process, specifically under the traditional review route with a decision code of SESE (Substantially Equivalent). This means the FDA determined it is substantially equivalent to a legally marketed device in terms of technology and intended use, allowing it to be legally marketed for its specified diagnostic imaging applications in digital mammography.

• What regulatory pathway was followed for the 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2), and which advisory committee was involved?

  The device was reviewed under the FDA’s 510(k) pathway, with the Radiology (RA) advisory committee providing input. The submission was filed under product code LLZ, which categorizes it within image display systems for radiology use. The review confirmed its substantial equivalence to a predicate device.