# K162497: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR

- Pathway: 510(k) (Traditional)
- Applicant: Eizo Corporation
- Decided: Sep 19, 2016 after 12 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.
14 later devices descend from it; 2 cite it directly.
0 of 17 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
- K172738: RadiForce RX560, RX560-AR (2017), 11 descendants of its own
- K223423: 32HQ713D (2023), 3 descendants of its own
- K200485: RadiForce RX1270, RadiForce RX1270-AR (2020), 3 descendants of its own
- K230845: 32HL512D, 31HN713D, 32HQ713D (2023), 2 descendants of its own
- K231026: 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) (2023), 1 descendant 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/K162497
Methodology: https://510kreport.com/methodology