# K102023: Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3L60C

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments (Siui
- Decided: Oct 19, 2010 after 92 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110841: Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array Transducer (2011), 6 descendants of its own
- K160853: Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System (2016), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K102023
Methodology: https://510kreport.com/methodology