# K043122: SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel Display

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Feb 9, 2005 after 89 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K001753 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041508: Barcoview Coronis 5MP HD Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 1.

## Indications for use
The SMD 21500 / DSB-2103-D-5MP device is intended to be used in displaying and viewing digital images for review by trained .medical practitioners. It is especially designed for digital mammography applications.

Source page: https://510kreport.com/device/K043122
Methodology: https://510kreport.com/methodology