# Qingdao Hisense Medical Equipment Co., Ltd.

- Location (FDA's records): Qingdao, CN
- FDA decisions: 9 (2015–2024): 9 510(k) clearances
- Product codes: PGY (5), IYN (3), IYO (1)
- 510(k) review time since 2016: median 115 days, against 60 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 16 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Barco N.V.: 4 (https://510kreport.com/company/barco)
- Nanjing Jusha Display Technology Co., Ltd.: 3 (https://510kreport.com/company/nanjing-jusha-display-technology)
- Shenzhen Beacon Display Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-beacon-display-technology)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 1 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Jvckenwood Corporation: 1 (https://510kreport.com/company/jvckenwood)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Eizo Corporation: 1 (https://510kreport.com/company/eizo)
- Barcoview: 1 (https://510kreport.com/company/barcoview)

## Firms that cite its devices most
- Contec Medical Systems Co.,Ltd: 1 (https://510kreport.com/company/contec-medical-systems)

## Its most-cited devices
- K213862: HD60 Series Ultrasound Diagnostic System (2022), cited by 3

## Recent decisions
- K233841: HD80 Series Ultrasound Diagnostic System (May 16, 2024)
- K233439: HD60 Series Ultrasound Diagnostic System (Feb 21, 2024)
- K222208: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D (Nov 17, 2022)
- K222132: Hisense LCD monitor HMD2G21S, HMD3G21S (Nov 8, 2022)
- K221567: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (Jul 26, 2022)
- K213862: HD60 Series Ultrasound Diagnostic System (Jun 8, 2022)
- K160347: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (Mar 3, 2016)
- K152030: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (Sep 16, 2015)

Source page: https://510kreport.com/company/qingdao-hisense-medical-equipment