# K233336: 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

- Pathway: 510(k) (Traditional)
- Applicant: Acula Technology Corp.
- Decided: May 21, 2024 after 235 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: 8 generations back to K000293 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201211: 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+, Shenzhen Beacon Display Technology Co., Ltd. (2020) Summary page 4.

## Indications for use
The 3MP Color LCD Display UMD3-21B01 (MD3-21B01) 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/K233336
Methodology: https://510kreport.com/methodology