# K160347: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
- Decided: Mar 3, 2016 after 24 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: 7 generations back to K001753 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091172: Nio 2MP (MDNG-2121), Barco N.V. (2009) Summary page 4.
- K131246: Coronis 3MP, Barco N.V. (2013) Summary page 4.
- K062131: Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB, Barcoview (2006) Summary page 4.

## Indications for use
The 2MP/3MP LCD Monitor (HMD2G21/HMD3G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners, including digital mammography.

Source page: https://510kreport.com/device/K160347
Methodology: https://510kreport.com/methodology