# K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Jul 2, 2019 after 64 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: 3 generations back to K103792 (2011). 3 ancestors in all.
6 later devices descend from it; 4 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)
- K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550), Jvckenwood Corporation (2016) Summary page 4.

## Most influential descendants
- K200864: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ (2020), 2 descendants of its own
- K253242: LCD Monitor (C1216W, C822W, C821W) (2025), 0 descendants of its own
- K241499: 21.3” 5MP Color LCD Display UMD5-21B01 (2024), 0 descendants of its own
- K233897: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) (2024), 0 descendants of its own
- K221567: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (2022), 0 descendants of its own

## Indications for use
CL-S500 and MS-S500 are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Source page: https://510kreport.com/device/K191137
Methodology: https://510kreport.com/methodology