# K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Feb 23, 2016 after 18 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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 K103792 (2011). 2 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151883: 5MP Monochrome LCD Monitor, RadiForce GX540, Eizo Corporation (2015) Summary page 4.

## Most influential descendants
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (2019), 6 descendants of its own
- K200864: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (2020), 2 descendants of its own
- K170781: MX50N (MX50YQS) (2017), 1 descendant of its own
- K170783: CX50N (CX50YQS) (2017), 1 descendant of its own
- K253242: LCD Monitor (C1216W, C822W, C821W) (2025), 0 descendants of its own

## Indications for use
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis

Source page: https://510kreport.com/device/K160326
Methodology: https://510kreport.com/methodology
