# K151883: 5MP Monochrome LCD Monitor, RadiForce GX540

- Pathway: 510(k) (Traditional)
- Applicant: Eizo Corporation
- Decided: Jul 30, 2015 after 21 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: 1 generation back to K103792 (2011). 1 ancestor in all.
30 later devices descend from it; 6 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103792: Barco Mammo Tomosynthesis, Barco N.V. (2011) Summary page 4.

## Most influential descendants
- K162497: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR (2016), 14 descendants of its own
- K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (2016), 12 descendants of its own
- K172738: RadiForce RX560, RX560-AR (2017), 11 descendants of its own
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (2019), 6 descendants of its own
- K223423: 32HQ713D (2023), 3 descendants of its own

## Indications for use
This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K151883
Methodology: https://510kreport.com/methodology