# K241499: 21.3” 5MP Color LCD Display UMD5-21B01

- Pathway: 510(k) (Traditional)
- Applicant: Acula Technology Corp.
- Decided: Jun 13, 2024 after 16 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: 5 generations back to K103792 (2011). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200864: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+, Shenzhen Beacon Display Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
UMDS5-21B01 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/K241499
Methodology: https://510kreport.com/methodology