# K243221: RadiForce RX570; RadiForce RX570-AR

- Pathway: 510(k) (Abbreviated)
- Applicant: Eizo Corporation
- Decided: Nov 27, 2024 after 51 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: 4 generations back to K103792 (2011). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172738: RadiForce RX560, RX560-AR, Eizo Corporation (2017) Summary page 5.
- K151883: 5MP Monochrome LCD Monitor, RadiForce GX540, Eizo Corporation (2015) Summary page 5.

## Indications for use
This product is intended for use in clinical radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Source page: https://510kreport.com/device/K243221
Methodology: https://510kreport.com/methodology