# K160853: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
- Decided: Jun 27, 2016 after 91 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: 19 generations back to K935595 (1995). 178 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110841: Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer, Shantou Institute of Ultrasonic Instruments (Siui (2011) Summary page 18.
- K141846: Acuson X700 Ultrasound System, Acuson X600 Ultrasound System, Siemens Medical Solutions USA, Inc. (2014) Summary page 18.

## Most influential descendants
- K173000: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (2017), 3 descendants of its own
- K243178: Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (2025), 0 descendants of its own
- K243132: Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) (2024), 0 descendants of its own
- K210317: Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System (2021), 0 descendants of its own
- K210318: Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System (2021), 0 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-vaginal, Trans-rectal, Obstetrics/ Gynecology and Urology applications.

Source page: https://510kreport.com/device/K160853
Methodology: https://510kreport.com/methodology