# K221567: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
- Decided: Jul 26, 2022 after 56 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 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.
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500, Jvckenwood Corporation (2019) Summary page 4.

## Indications for use
HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography. HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Source page: https://510kreport.com/device/K221567
Methodology: https://510kreport.com/methodology