# K192152: DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Dec 13, 2019 after 126 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K935595 (1995). 293 ancestors in all.
6 later devices descend from it; 2 cite it directly.
6 of 300 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181637: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 43.

## Most influential descendants
- K213862: HD60 Series Ultrasound Diagnostic System (2022), 3 descendants of its own
- K201693: DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (2020), 1 descendant of its own
- K233841: HD80 Series Ultrasound Diagnostic System (2024), 0 descendants of its own
- K232908: Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) (2024), 0 descendants of its own
- K233439: HD60 Series Ultrasound Diagnostic System (2024), 0 descendants of its own

## Indications for use
The DC-80/DC-80 PRO/DC-80 EXP/DC-SOS/J)C-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultxjasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , trans-esoph. (Cardiac), peripheral vessel, and urology exams.

Source page: https://510kreport.com/device/K192152
Methodology: https://510kreport.com/methodology