Smd 21500 or Dsb-2103-D-5MP-5M Pixel Grayscale Flat Panel Display

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

510(k) Number

K043122 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.via

  Class II

  FDA 510(k) K123375 Active Cleared 20 Nov 2012

• Dental X-Ray Unit

  Class II

  FDA 510(k) K781286 Active Cleared 11 Sep 1978

• Siemens Polydoros 800

  Class I

  FDA 510(k) K820112 Active Cleared 24 Feb 1982

• Opti 110/12/50HSG

  Class I

  FDA 510(k) K810190 Active Cleared 2 Mar 1981

• Optiplanimat

  Class II

  FDA 510(k) K781531 Active Cleared 14 Sep 1978

• Somatom 2

  Class II

  FDA 510(k) K790975 Active Cleared 30 Jul 1979

See all devices from Siemens Corp. →

• What is the SMD 21500 / DSB-2103-D-5MP used for in medical imaging?

  The SMD 21500 / DSB-2103-D-5MP Grayscale Flat Panel Display is designed specifically for radiologic imaging to capture and display high-resolution X-ray images. It converts radiographic exposure into a digital signal, enabling clear visualization of anatomical structures for accurate diagnostic evaluation in radiology departments. This makes it essential for real-time imaging tasks where precise image reproduction is critical.

• Is the SMD 21500 / DSB-2103-D-5MP a single-use or reusable device?

  The SMD 21500 / DSB-2103-D-5MP is a reusable component. Unlike disposable devices, it is intended for repeated use within radiology workflows, provided it undergoes proper handling, maintenance, and cleaning as recommended by the manufacturer. This ensures consistent performance and longevity in clinical settings.

• What pixel density does the SMD 21500 / DSB-2103-D-5MP offer, and why is it important?

  The SMD 21500 / DSB-2103-D-5MP features a 5-megapixel (5MP) resolution, which translates to a high pixel density for capturing detailed medical images. This level of resolution ensures finer anatomical details are visible, improving diagnostic accuracy for radiologists. Higher pixel density reduces pixelation and enhances the clarity of soft tissues and subtle structures in X-ray images.

• Are there any sterility requirements for the SMD 21500 / DSB-2103-D-5MP?

  The manufacturer does not specify any sterility requirements for the SMD 21500 / DSB-2103-D-5MP. Since it is a reusable flat panel display used in radiology, its primary focus is on maintaining cleanliness and functionality rather than sterility. Proper cleaning protocols should follow the manufacturer’s guidelines to prevent contamination and ensure optimal performance.

• How should the SMD 21500 / DSB-2103-D-5MP be stored to avoid damage?

  The SMD 21500 / DSB-2103-D-5MP should be stored according to the manufacturer’s guidelines to prevent physical damage, environmental exposure, or performance degradation. This typically includes storing it in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. Proper handling and storage ensure the display remains functional and ready for use in radiologic imaging workflows.