# K221061: 21HQ613D

- Pathway: 510(k) (Traditional)
- Applicant: Lg Electronics.Inc
- Decided: Jun 3, 2022 after 53 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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.
- K201777: 31HN713D, Lg Electronics.Inc (2020) Summary page 5.

## Most influential descendants
- K240130: Medical Monitor (21HQ613D) (2024), 0 descendants of its own

## Indications for use
This Medical Monitor is indicated for use in displaying 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/K221061
Methodology: https://510kreport.com/methodology