# 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

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd.
- Decided: Mar 31, 2025 after 182 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: 21 generations back to K935595 (1995). 181 ancestors in all.
No later device cites it as a predicate yet.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173000: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) (2017) Summary page 6.

## Indications for use
The system is intended to be used by a trained/qualified healthcare professional in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ (thyroid, testes, breast), neonatal cephalic, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), liver, peripheral vascular, trans-vaginal, trans-rectal, obstetrics/ gynecology and urology applications in B-Mode(B, 2B, 4B), M-Mode, Anatomical M-mode, Color M, Color Flow Map (CFM), Power Doppler Imaging (PDI), Directional Power Doppler Imaging (DPDI), Pulsed Wave Doppler (PWD), Continuous Wave Doppler(CWD), 3D/4D, Elastography, Contrast Harmonic Imaging(CHI), S-Beam, Panoscope, Trapezoidal/Extended Sector Imaging, Tissue Doppler Imaging(TDI), Tissue Harmonic Imaging(THI), Macro Fidelity Imaging(MFI), ECG, Vector Space Flow (VS Flow), DICOM.

Source page: https://510kreport.com/device/K243178
Methodology: https://510kreport.com/methodology