# K190153: RadiForce MX216

- Pathway: 510(k) (Abbreviated)
- Applicant: Eizo Corporation
- Decided: Mar 8, 2019 after 37 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 K092613 (2010). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131090: 2MP Color LCD Monitor, Radiforce MX215, Eizo Corporation (2013) Summary page 4.

## Most influential descendants
- K230684: RadiForce MX217 (2023), 1 descendant of its own
- K252780: LCD Monitor (CL1902A, CL2103F) (2025), 0 descendants of its own

## Indications for use
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Source page: https://510kreport.com/device/K190153
Methodology: https://510kreport.com/methodology