# K222132: Hisense LCD monitor HMD2G21S, HMD3G21S

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
- Decided: Nov 8, 2022 after 112 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183497: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor, Nanjing Jusha Display Technology Co., Ltd. (2019) Summary page 5.
- K141690: Jusha-M33C LCD Monitor, Nanjing Jusha Display Technology Co., Ltd. (2014) Summary page 5.

## Indications for use
1) The 2MP Monochrome LCD Monitor HMD2G21S is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis. 2)The 3MP Monochrome LCD Monitor HMD3G21S is intended to be used in displaying and viewing digital images for diagnosis X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Source page: https://510kreport.com/device/K222132
Methodology: https://510kreport.com/methodology