# K213862: HD60 Series Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Hisense Medical Equipment Co., Ltd.
- Decided: Jun 8, 2022 after 180 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: 28 generations back to K935595 (1995). 294 ancestors in all.
3 later devices descend from it; 3 cite it directly.
6 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- 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 HD60 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment. The systems support the following clinical applications: The HD60 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams. Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

Source page: https://510kreport.com/device/K213862
Methodology: https://510kreport.com/methodology