# K063289: 2MP Medical Monochrome Reference Display, Model MDM2130-2NC

- Pathway: 510(k) (Traditional)
- Applicant: Chi Lin Technology Co., Ltd.
- Decided: Nov 16, 2006 after 15 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: 5 generations back to K000293 (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)
- K061303: Medical Display, Models MDM 1900-1NG and MDM 1900-1NR, Chi Lin Technology Co., Ltd. (2006) Summary page 1.

## Indications for use
2MP Medical Monochrome Reference Display, MDM2130-2NC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Source page: https://510kreport.com/device/K063289
Methodology: https://510kreport.com/methodology