# K053039: Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000, DL3000, DL2000 of and DL3000 of

- Pathway: 510(k) (Traditional)
- Applicant: Clinton Electronics Corp.
- Decided: Mar 1, 2006 after 125 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032638: Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray, Planar Systems, Inc. (2003) Summary page 2.
- K042660: Nio 2MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 2.

## Indications for use
The Clinton Electronics Corp. DL Series II Flat-Panel Displays are intended for use in displaying and viewing digital images by trained medical practitioners. The Displays are not intended for and should not be used for primary diagnosis in digital mammography.

Source page: https://510kreport.com/device/K053039
Methodology: https://510kreport.com/methodology