# K123944: Kostec Medical Grade LDC Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Kostec Co., Ltd.
- Decided: Sep 5, 2013 after 259 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: 7 generations back to K913770 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052120: Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50, Heeyoung Co., Ltd. (2005) Summary page 1.

## Indications for use
The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.

Source page: https://510kreport.com/device/K123944
Methodology: https://510kreport.com/methodology
