# K050619: 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Apr 26, 2005 after 47 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: 2 generations back to K032555 (2004). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043430: 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB, Totoku Electric Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K072065: 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2) (2007), 5 descendants of its own
- K081056: 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A) (2008), 4 descendants of its own
- K112604: 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356) (2011), 3 descendants of its own
- K133185: 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358) (2013), 2 descendants of its own
- K140214: 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6) (2014), 1 descendant of its own

## Indications for use
20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Source page: https://510kreport.com/device/K050619
Methodology: https://510kreport.com/methodology